Engineer/Senior Engineer, Device Development (Relocation Assistance Available) - United Therapeutics
Eden Prairie, MN
About the Job
California, US residents click here (https://www.unither.com/docs/UNITHER%20Applicant%20Notice%20-%20%2812-22-23%29%20Final%202.15.24%20Combined%20EN%20and%20French.pdf#page=9) .
The job details are as follows:
What We Do
We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.
We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.
Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases.
How you’ll contribute
The Senior Engineer, Device Development is responsible for leading research and development of medical device products and components used in combination products by applying technical and subject matter expertise. This role involves identifying and solving problems, leading product design and development projects, and supporting the R&D team in developing advanced organ therapeutics. This individual must be an innovative, adaptive, self-motivated, and experienced engineer eager to work cross functionally to define the proposed design, generate appropriate design control documentation, conduct verification and validation testing, and complete risk management activities.
+ Develop the design control and risk management strategies for projects based on relevant regulations, industry standards, and the project scope
+ Provide technical input and guidance in defining project priorities and timelines and crafting department goals
+ Provide coaching, mentoring, and technical guidance to junior members of the team
+ Develop preliminary device component designs that integrate seamlessly with biologic components of combination products
+ Produce design prototypes and conduct feasibility performance evaluations to inform design selection and design freeze
+ Develop and document design input requirements and user needs
+ Define and create design output documentation including specifications and labeling
+ Develop strategies for and participate in execution of verification and validation testing while maintaining appropriate testing and traceability documentation
+ Author, review, and approve protocols, reports, and other supporting documentation for design verification and validation
+ Lead risk management strategy development and conduct and document risk analysis activities such as PHA, dFMEA, and uFMEA as required by the risk management plan
+ Communicate relevant information regarding project status, design details, and deliverable content to peer collaborators and executive stakeholders
+ Collaborate with Quality, Regulatory, and other stakeholders on reviewing and approval completed documentation
+ Serve as process owner for creating, organizing, and managing Design History Files
+ Manage current relationships and develop new relationships with strategic business partners and external collaborators to represent the company and advance R&D projects
+ Proactively identify technical needs of the Downstream R&D teams and ensure appropriate levels of support including work that may involve cells, tissues, and other biologic source materials
+ Develop strategy for documenting and securing intellectual property
+ All other duties as required
For this role you will need
Minimum Requirements for _Engineer, Device Development_
+ Bachelor’s Degree in materials science, chemical, biomedical, or mechanical engineering and 2+ years of relevant experience or a Master's degree with some relevant experience
+ Technical expertise in ISO 13485 compliant Design Control and ISO 14971 compliant Risk Management activities
+ Skilled at managing complex details, schedules, and timelines in support of design and development projects
+ Knowledge of good documentation and good manufacturing practices
+ Ability to use mathematics to solve problems
+ Ability to organize, analyze, and present complex data
+ Excellent written and oral communication skills
Minimum Requirements for _Senior Engineer, Device Development_
+ Bachelor’s Degree in materials science, chemical, biomedical, or mechanical engineering and 5+ years of relevant experience (or 3+ years of relevant post-masters experience or 1+ year of relevant post-doctorate experience)
+ 3+ years of experience performing ISO 13485 compliant design control activities
+ 3+ years of experience performing ISO 14971 compliant risk management activities
+ Experience in prototype design and construction
+ Ability to use mathematics to solve problems
+ Ability to organize, analyze, and present complex data
+ Work effectively with a cross-functional team to make project decisions
+ Ability to work independently and as part of a team
+ Excellent written and oral communication skills
Preferred Qualifications for _Engineer, Device Development_
+ Master’s Degree in materials science, chemical, biomedical, or mechanical engineering
+ Experience in rapid prototyping and/or component fabrication and manufacturing processes
+ Experience with combination products that include device and biologic components
+ Knowledge of kidney and liver anatomy, biology, and physiology
+ Proficient in statistical analysis
+ Ability to work independently and as part of a team
Preferred Qualifications for _Senior Engineer, Device Development_
+ Master’s Degree in materials science, chemical, biomedical, or mechanical engineering or Doctor of Philosophy (PhD) in materials science, chemical, biomedical, or mechanical engineering
+ Proficient in statistical analysis
+ Proficiency with 3D modeling software (SolidWorks, OnShape, Fusion 360, Creo, etc.)
+ Proficiency in 3D printing and other rapid prototyping methodologies
+ Experience with combination products that include device and biologic components
At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.
The salary for the Engineer, Device Development (Miromatrix) position ranges from $80,000 to $105,000 per year. The salary for the Senior Engineer, Device Development (Miromatrix) position ranges from $102,000 to $130,000. In addition, this role is eligible for the Company’s short-term and long-term incentive programs. Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities .
The salary range is the range United Therapeutics Corporation in good faith believes is the range of possible compensation for this role at the time of this posting depending on the candidate’s experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range. This range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.
Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
_While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients._
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities
_We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._
_We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._
The job details are as follows:
What We Do
We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.
We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.
Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases.
How you’ll contribute
The Senior Engineer, Device Development is responsible for leading research and development of medical device products and components used in combination products by applying technical and subject matter expertise. This role involves identifying and solving problems, leading product design and development projects, and supporting the R&D team in developing advanced organ therapeutics. This individual must be an innovative, adaptive, self-motivated, and experienced engineer eager to work cross functionally to define the proposed design, generate appropriate design control documentation, conduct verification and validation testing, and complete risk management activities.
+ Develop the design control and risk management strategies for projects based on relevant regulations, industry standards, and the project scope
+ Provide technical input and guidance in defining project priorities and timelines and crafting department goals
+ Provide coaching, mentoring, and technical guidance to junior members of the team
+ Develop preliminary device component designs that integrate seamlessly with biologic components of combination products
+ Produce design prototypes and conduct feasibility performance evaluations to inform design selection and design freeze
+ Develop and document design input requirements and user needs
+ Define and create design output documentation including specifications and labeling
+ Develop strategies for and participate in execution of verification and validation testing while maintaining appropriate testing and traceability documentation
+ Author, review, and approve protocols, reports, and other supporting documentation for design verification and validation
+ Lead risk management strategy development and conduct and document risk analysis activities such as PHA, dFMEA, and uFMEA as required by the risk management plan
+ Communicate relevant information regarding project status, design details, and deliverable content to peer collaborators and executive stakeholders
+ Collaborate with Quality, Regulatory, and other stakeholders on reviewing and approval completed documentation
+ Serve as process owner for creating, organizing, and managing Design History Files
+ Manage current relationships and develop new relationships with strategic business partners and external collaborators to represent the company and advance R&D projects
+ Proactively identify technical needs of the Downstream R&D teams and ensure appropriate levels of support including work that may involve cells, tissues, and other biologic source materials
+ Develop strategy for documenting and securing intellectual property
+ All other duties as required
For this role you will need
Minimum Requirements for _Engineer, Device Development_
+ Bachelor’s Degree in materials science, chemical, biomedical, or mechanical engineering and 2+ years of relevant experience or a Master's degree with some relevant experience
+ Technical expertise in ISO 13485 compliant Design Control and ISO 14971 compliant Risk Management activities
+ Skilled at managing complex details, schedules, and timelines in support of design and development projects
+ Knowledge of good documentation and good manufacturing practices
+ Ability to use mathematics to solve problems
+ Ability to organize, analyze, and present complex data
+ Excellent written and oral communication skills
Minimum Requirements for _Senior Engineer, Device Development_
+ Bachelor’s Degree in materials science, chemical, biomedical, or mechanical engineering and 5+ years of relevant experience (or 3+ years of relevant post-masters experience or 1+ year of relevant post-doctorate experience)
+ 3+ years of experience performing ISO 13485 compliant design control activities
+ 3+ years of experience performing ISO 14971 compliant risk management activities
+ Experience in prototype design and construction
+ Ability to use mathematics to solve problems
+ Ability to organize, analyze, and present complex data
+ Work effectively with a cross-functional team to make project decisions
+ Ability to work independently and as part of a team
+ Excellent written and oral communication skills
Preferred Qualifications for _Engineer, Device Development_
+ Master’s Degree in materials science, chemical, biomedical, or mechanical engineering
+ Experience in rapid prototyping and/or component fabrication and manufacturing processes
+ Experience with combination products that include device and biologic components
+ Knowledge of kidney and liver anatomy, biology, and physiology
+ Proficient in statistical analysis
+ Ability to work independently and as part of a team
Preferred Qualifications for _Senior Engineer, Device Development_
+ Master’s Degree in materials science, chemical, biomedical, or mechanical engineering or Doctor of Philosophy (PhD) in materials science, chemical, biomedical, or mechanical engineering
+ Proficient in statistical analysis
+ Proficiency with 3D modeling software (SolidWorks, OnShape, Fusion 360, Creo, etc.)
+ Proficiency in 3D printing and other rapid prototyping methodologies
+ Experience with combination products that include device and biologic components
At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.
The salary for the Engineer, Device Development (Miromatrix) position ranges from $80,000 to $105,000 per year. The salary for the Senior Engineer, Device Development (Miromatrix) position ranges from $102,000 to $130,000. In addition, this role is eligible for the Company’s short-term and long-term incentive programs. Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities .
The salary range is the range United Therapeutics Corporation in good faith believes is the range of possible compensation for this role at the time of this posting depending on the candidate’s experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range. This range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.
Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
_While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients._
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities
_We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._
_We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._
Source : United Therapeutics