The Senior Manufacturing Engineering role is a great opportunity to support the IHFM manufacturing team as we begin to set up operations in Irvine. In this role you will begin by setting up the distribution and servicing operations for one of our most recent acquisitions. Upon successful setup in Irvine, you will join the team responsible for transferring our first sensor manufacturing line to Irvine. You will also support the IHFM team by managing engineering activities such as new product introductions, stabilization activities, and commercial manufacturing.
How you’ll make an impact:
Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes (IQ/OQ/PQ/SWV/TMV); analyze results, make recommendations, and develop reports.
Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.
Identify 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.
Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).
Lead and establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).
Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work.
Perform other duties and responsibilities as assigned.
What we look for:
What else we look for:
Class II and Class III medical device manufacturing experience.
Lean Six Sigma certification.
Extensive knowledge and understanding of principles, theories, and concepts relevant to Engineering as well as the production development process (PDP).
Experience with Windchill PTC.
Proven expertise in usage of MS Office Suite.
Effective communication and project management skills.
Strong analytical, problem solving, and technical writing skills.
Ability to work well independently based on minimal guidance.
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California, the base pay range for this position is $108,000 to $153,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).Applications will be accepted while this position is posted on our Careers website.
