Senior Process Engineer - Assembly

Job Title: Senior Process Engineer - Assembly

Location: Milwaukee, WI

Type: Direct Hire

Schedule: Monday - Friday, 8am - 5pm

Pay Range: $100k - $120k bonus

Benefits: Yes. Medical, Dental, Vision, PTO, 401(k), Paid holidays

Summary

Connect Search is hiring a Senior Process Engineer - Assembly in Milwaukee.

Responsibilities

• Review customer prints, BOMs, and specifications for assembly feasibility and build sequence; identify sub-assembly breakdown and flag Design for Assembly (DFA) issues to customers and Sales
• Provide build time, tooling, and fixture cost estimates to support quoting activities
• Define assembly sequence and station/line layout from sub-assembly stations through final assembly
• Design or source fixtures, jigs, and torque/fastening tools; set and validate torque specs, adhesive/sealant parameters, and press-fit forces
• Define kitting requirements per station and procure prototype/first article hardware and sub-assembly components
• Plan and run first article sub-assembly and final assembly builds; verify integration, fit, function, and torque retention
• Lead root cause analysis and containment on issues found during pilot builds
• Complete first article inspection (FAI) reports and customer approval packages; validate repeatability of critical joins
• Author work instructions per station, including torque/fastener callouts; complete PFMEAs and control plans for each sub-assembly and integration step
• Define operator training/certification requirements per station
• Assemble the process handoff package and lead the formal handoff review with Manufacturing Engineering; remain available as an escalation point during the post-handoff support window
• Follow and comply with all safety and work rules and regulations
• Independently own moderate-to-high complexity design transfers end-to-end, from DFA review and quoting support through first article, validation, and handoff
• Lead process development, sequencing, and fixture/tooling design for multi-station sub-assembly and final assembly builds
• Lead process capability studies (e.g., Cpk) on critical joins; support IQ/OQ activities where required
• Author and review PFMEAs, control plans, and validation protocols
• Lead root cause investigation and containment on pilot and early-production issues, coordinating with Quality and Manufacturing Engineering
• Represent Process Engineering in customer design reviews and first article approvals
• Identify and lead moderate-scope continuous improvement and cost-reduction initiatives within assigned programs
• Contribute to departmental templates and best practices for work instructions, PFMEA methodology, and validation protocols
• Mentor Process Engineer I team members
• 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

Qualifications

• 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
• Lean or Six Sigma certification (Green Belt or higher) and medical device assembly experience preferred