Principal Engineer, Manufacturing

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Job description

Permanent/Direct Hire Principal Engineer in Manufacturing

Currently seeking a Principal Engineer, Manufacturing for a client in the medical device industry located in Irvine, CA. For immediate consideration please email Lauren Pritts,

Job Description Summary:

The Principal Engineer, Manufacturing will serve as a main interface between R&D, Pilot and commercial manufacturing, contribute to the THV valve product life cycle from Early Human Use to commercialization, and the development of new or optimized manufacturing processes. The Principal Process Development Engineer will also be instrumental in new manufacturing facility validation.

Job Responsibilities:

• Technical engineering support for the design transfer and pilot production of THV clinical devices, as well as commercialization activities, by ensuring R&D processes are characterized and scaled up by utilizing new technology and standard work.
• Partner with Quality and R&D Engineers to develop and validate critical processes in the Development and Operations environment. Lead in the identification and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc. are up to standards.
• Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.
• Equipment, tooling and fixture design support and selection for Development and Operations activities, including cost assessment, cost reductions and product reliability improvement.
• Critical review and approval of design changes. Partner with R&D as the Operations technical representative in the transfer of safe and effective THV devices.
• Technical quality support for design qualifications, design transfer, activities for Regulatory submissions, product and process development and implementation of design control documents, and approval of product/process change.
• Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).
• Oversee manufacturing support tasks; give instruction to engineers/ technicians on conducting tests; train engineers/ technicians and provide feedback; and coordinate engineer/ technician work.
• Train, coach, and guide lower level employees on more complex procedures.
• Lead and establish complex project plans to ensure deliverables are completed to customer's expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).
• Drive the development and manage the execution of complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports.
• Technical management of Development and Manufacturing-related team projects.

Required Education and Experience:

• A Bachelor of Science degree in Mechanical or Biomedical Engineering (or equivalent engineering degree) is required.
• Minimum of 7 years' experience in Medical Device Development or Manufacturing environment is required.
• Knowledge of equipment qualification and design verification, process validation in the medical device industry or other regulated industries is required.
• Understanding of statistical techniques is required and must be able to effectively articulate (verbally and in writing) results and conclusions to technical and non-technical personnel.

Preferred Qualifications:

• Medical device manufacturing experience in heart valves, stents, catheters, delivery systems and/or interventional access devices is preferred
• Master's degree in Engineering
• Project Management Certification
• Six Sigma Black Belt and/or Lean Mfg Certification

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or . - provided by Dice