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As a part of the global industrial organization Marmon Holdingswhich is backed by Berkshire Hathawayyoull be doing things that matter leading at every level and winning a better way. Were committed to making a positive impact on the world providing you with diverse learning and working opportunities and fostering a culture where everyones empowered to be their best.
Job Scope
The Senior Manufacturing Engineer (SME) supports the life cycle of Acumed medical devices driving process development integration validation and continuous improvement. This role ensures operational objectives in COGS OTD and NPI while maintaining GMP compliance. The SME eliminates waste optimizes processes and enhances manufacturing efficiency.
The ideal candidate is passionate about manufacturing and machining thrives in a regulated quality-first environment and excels in technical writing problem-solving and shop floor collaboration. This role also involves mentorship technical leadership and strategic planning.
Duties & Responsibilities
Develop integrate and validate production processes.
Lead new product launches and process validation (IQ OQ PQ).
Serve as SME for machining processes and shop floor inspection methods.
Apply DFM/A principles to optimize manufacturability and product quality.
Evaluate and justify capital equipment purchases (ROI analysis).
Oversee selection and commissioning of new production equipment.
Implement Lean tools and lead process improvement initiatives.
Manage corrective/preventative actions (CAR/SCAR) and risk-based inspection strategies.
Utilize statistical analysis tools (Minitab JMP etc.) for process capability and validation.
Act as a key liaison for audits and cross-functional initiatives.
Communicate effectively across all organizational levels.
Qualifications
B.S. in Engineering (Mechanical Manufacturing Industrial) or equivalent.
5 years of manufacturing engineering or related experience.
Advanced experience and knowledge in CNC machining and programming
3D CAD experience (Autodesk Inventor SolidWorks PRO-E etc.).
Strong understanding of GD&T.
Experience with ROI analysis capital equipment selection and process validation.
Knowledge of FDA and ISO 13485 regulations.
Experience with statistical tools (Minitab JMP etc.).
Following receipt of a conditional offer of employment candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.
We are an equal opportunity employer and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process please email your request to and please be sure to include the title and the location of the position for which you are applying.
Required Experience:
Senior IC
Full-Time