Principal Mechanical Engineer - Merz North America, Inc
Raleigh, NC 27601
About the Job
Provide mechanical engineering expertise from product prototype and development through commercialization. Design and build medical devices, including proof of concept designs, for systems involving motion with ultrasound imaging and therapy delivery that are electro-mechanical in nature. Provide product design guidance and consultation support on commercialized product.
Responsibilities
- Design and develop new products, components, or accessories, define requirements and support selection of production/commercialization process.
- Design, develop and support proof-of-concept and early development prototypes for new technology and features to support product road map.
- Provide continuing product support for manufacturing, regulatory and quality on design requirements, customer needs, testing, CAPA, reliability predictions, and product documentation.
- Working within the Product Development Process complete assigned projects with internal team members and qualified external development partners.
- Apply Risk Management and Hazard Analysis process to new product designs, product upgrades, and field failures as the product development subject matter expert.
- Substantiate product design by developing test plans, performing design analysis, making design adjustments, running performance calculations, and maintaining quality standards.
- Ensure compliance to the requirements of ISO 13485 standards, FDA regulations and Good Manufacturing Processes regarding design and development of new product designs and product upgrades.
- Create, define, and drive approvals for SOWs required for vendors and design partners
- Responsible for guidance of the proper implementation of Design Controls at the MDIC site and representation of the Product Development process for audits.
- Support of the Document Change Notice (DCN) and Change Request (CR) processes per Design Controls – Design Change regulations and internal policies.
Education
- Bachelor in Mechanical Engineering or Electrical Engineering or equivalent experience required
- Master in Mechanical Engineering preferred
Professional experience
- 12+ years total Mechanical Engineering experience
- 7+ years of related design and development experience in medical devices
- Experience collaborating with design partners/contract engineering firms to design and develop a medical device.
- Experience with oversight of contract test agencies, including problem resolution, for standardized testing.
- Experience with medical devices with integrated software, hardware, and firmware.
- Experience with IEC 60601-1 and -2 Medical Device Safety testing
- Experience with on FDA QSR (21 CFR 820), ISO 13485, ISO 14971
- Exposure to software development practices and IEC 62304.
Knowledge, skills, and abilities
- FDA Design Controls for medical devices
- EU Medical Device Directive (CE Marking requirements)
- Knowledge and experience with application of Six Sigma statistical analysis and controls
- Understanding and experience in product design and development including the use of tools such as FEA, Risk Analysis, DFMA, GD&T, and DFMEA
- Strong design and documentation skills using the Solidworks CAD application
- Strong experience in material knowledge, molding, and tooling for manufacturing.
- Strong experience in designing mechanical fixtures to support design and manufacturing.
- Excellent verbal and written communication.
- Proficient with Word, Excel, PowerPoint, and Project.
- Demonstrated ability to deliver results with minimal supervision in a timely manner.
- Ability to collaborate, communicate and coordinate cross-functionally.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c) Research and Development
Source : Merz North America, Inc