Senior Process Engineer - Assembly
About The Position
Process Engineering is responsible for developing new assembly and sub-assembly manufacturing processes for electromechanical products, from manufacturability review and quoting support through first article build, process validation, and release to Manufacturing Engineering. Process Engineering partners with Manufacturing Engineering, Quality, and customers to ensure new processes are producible, repeatable, and fully documented before transfer to production. This job class has four experience levels: Process Engineer I, Process Engineer II, Senior Manufacturing Process Engineer, and Principal Manufacturing Process Engineer.
Requirements
- 7 to 15 years of manufacturing or process engineering experience in mechanical/electromechanical assembly, including at least 3 years launching new assembly processes
- Led new process introductions from quote through first article, validation, and release to production
- Designed or specified assembly fixtures and tooling, and set torque/fastening, adhesive/sealant, and press-fit parameters for production
- Authored and maintained PFMEAs, control plans, and work instructions, including engineering change control and re-qualification on released processes
- Led root cause and corrective action investigations (8D, 5 Why, fishbone) that delivered measurable gains in yield, scrap, or cycle time
- Completed process validation (IQ/OQ/PQ) and FAI in an ISO 13485, ISO 9001, or similarly regulated environment
- Mentored engineers and trained or certified production operators
- Proficient in SolidWorks or equivalent CAD
Nice To Haves
- Lean or Six Sigma certification (Green Belt or higher)
- Medical device assembly experience
Responsibilities
- Serve as technical lead for assembly process development on assigned programs; apply and help develop engineering standards for fixtures, torque/fastening control, work instructions, PFMEAs, and control plans
- Own and continuously improve the NPD-to-Production handoff process, including handoff package requirements, joint walkthroughs, and the post-handoff support window
- Lead manufacturability reviews and drive DFA feedback to customers and Sales; develop and review build time, tooling, fixture, and capital cost estimates
- Lead process validation (IQ/OQ/PQ or equivalent) for new and changed processes
- Author and approve work instructions, DHR documents, PFMEAs, and process validations
- Present process plans, validation results, and corrective actions to customers and internal leadership
- Support customer and regulatory audits as the process subject-matter expert
- Prioritize and coordinate engineering workload across multiple programs with the Process Engineering Manager
- Review designs, documentation, and validation work completed by Process Engineer I and II team members
- Mentor Process Engineer I and II and Manufacturing Engineer team members
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What This Job Offers
Job Type
Full-time
Career Level
Senior
