Medical Device Mechanical Engineer - ACL Digital

Job Title: Senior Engineer

Location: Thousand Oaks CA

Duration: 12 Months

Description:

Hybrid - MUST BE LOCAL TO USTO and able to report onsite every week.

Monday, Wednesday, Friday (Remote)

Tuesday, Thursday (On site) 9am - 5pm (flex) / 7am- 4pm

Top 3 Must Have Skill Sets:

Engineering background (Mechanical, Biomedical, or Manufacturing)

Experience with CAD (Solidworks preferred) & fixture or component design experience

Experience working in a regulated field (Medical devices, pharmaceutical, Aerospace, etc.)

Looking for a candidate who has not job hopped every 6-8 months and has a solid root cause analysis skills, technical writing, statistical background, CAD skills, thinker, problem solver, etc

Mainly Mechanical, Manufacturing, Biomedical engineers. Coding skills is a plus but not required. Candidates experience with Instron (or any other Force Tester), Keyence is a huge plus. Not so much candidates with QA/QE background they are usually good with documents and statistics and not so much a problem solver or overall technical.

Job Summary

The Senior Engineer is responsible for engineering activities required for development / qualification / validation and transfer of GMP physical test methods for combination products, devices, primary container, and secondary packaging components, as required. This individual shall have the ability to work on multiple projects at one time that may involve either new or changed product, process, tooling or equipment introduction to improve product quality and reliability.

RESPONSIBILITIES:

• Assure transfer of new combination product test methods to QC or manufacturing, by developing six sigma processes and compiling all required documentation.

• Implement projects per Combination Product Operations (CPO) and company procedures to ensure projects are completed on schedule and within established budget.

• Apply core engineering principles to develop physical test methods for medical device and combination product systems.

• Perform data analysis to support method development, qualification, validation, and transfer

• Provide expert support in the design or redesign of tools and/or equipment required for manufacturing processes.

• Provide expert support for investigations as well as new processes development required to improve manufacturing operations. Improvements may be required for a variety of reasons (i.e. quality, reliability, new product introduction, cost saving).

• Coordinate gauge and equipment development and delivery with selected contractors.

• Ensure that qualification parameters are met for product assembly and performance requirements.

• Support development of cost estimates for new processes, gauges and equipment development used in generation of capital request documentation.

• Generate procedures necessary to support department and new product equipment.

• Provide expert training to individuals in the operation and maintenance of processes, gauges and equipment introduced to the manufacturing department (i.e. production operator, mechanics, process engineers).

• Participate in and assume responsibilities of team functions as assigned (i.e. Product Improvement Teams). Supervise work of support staff during development and manufacture of system.

• Excellent communication (written and verbal) and organizational skills

• Develops and maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project deliverables

• Networks with manufacturing, quality and regulatory organizations both internal and external to Amgen

• Facilitates robust horizontal communication to ensure all functions are aware of changes in deliverables and impacts to risk.

• Proactively identifies issues and/or risks and develops mitigation options to resolve or escalate efficiently

• Integrates partner/vendor timelines with Amgen timelines as appropriate

Basic Qualifications:

Doctorate Degree OR

Master's Degree and 3 years of Engineering experience

OR Bachelor's Degree and 5 years of Engineering experience

OR Associate's degree and 10 years of Engineering experience OR

High school diploma/GED and 12 years of Engineering experience.

Preferred Qualifications:

• M.S. or Ph. D. in Mechanical, Aerospace, Mechatronics, Chemical or Biomedical engineering

• Excellent written and verbal communication skills together with demonstrated ability to work in a highly matrixed team environment

• Experience with managing technical teams, including setting priorities and leveling resources

• Technical writing experience

• Spanish language skills preferred

• Experienced with SolidWorks (or other 3D-CAD software)

• Familiar with equipment and software IOQ

• Experience with process characterization, scale-up, technology transfer experience, pFMEAs and dFMEAs

• Experience with change controls, deviations, CAPA

• Experience with combination products and device regulatory requirements

• Understanding of the six sigma process, utilizing Minitab (or other statistical software packages) to solve statistical problems

• Work history with cGMPs, regulatory filings and compliance issues for sterile injectable products manufactured by aseptic processing

• Experience with machine controls (PLC, HMI) and vision systems

Basic Qualifications

Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience