Senior Manufacturing Engineer (Medtech)

TL;DR

Senior Manufacturing Engineer (Medtech): Lead development and optimization of manufacturing processes in clean rooms for medical devices with an accent on lean techniques, equipment layout, and validation strategies. Focus on implementing process improvements, ensuring scalability and regulatory compliance, and driving efficiency through structured problem-solving.

Location: Onsite in Plymouth, Minnesota, United States. Minimum 5 days a week onsite required. Unrestricted U.S. work authorization required (no sponsorship for this level).

Salary: $100,000 - $150,000 USD

Company

Global leader in healthcare technology with 95,000+ employees focused on innovative medical solutions.

What you will do

• Lead lean manufacturing processes, procedures, and production layouts for assemblies, equipment, and material handling.
• Design and arrange efficient machine layouts within plant facilities.
• Identify opportunities, develop business cases, and lead initiatives for process improvements including equipment curation and validation.
• Adapt machine designs to production conditions and ensure capable inspection/test requirements in control plans.
• Inspect machinery performance, investigate issues, and initiate corrective actions for product quality.
• Apply manufacturability analysis, Gage R&R statistics, and ensure compliance with regulations like 21 CFR 820.

Requirements

• Bachelor’s degree with 4+ years, Master’s with 2+ years, or PhD with 0 years of relevant experience.
• Expert understanding of manufacturing technologies and processes.
• Track record in process improvements, team leadership, and structured problem-solving.
• For degrees outside US: Must satisfy 8 C.F.R. § 214.2(h)(4)(iii)(A).
• Unrestricted U.S. work authorization at hire and throughout employment (no sponsorship).

Nice to Have

• 5+ years Manufacturing Engineering experience.
• GDP/GMP, IQ/OQ/PQ, Project Management, Lean Six Sigma.
• Validation planning, process mapping, FMEAs, statistical analysis (Minitab), CAD (Solidworks), SAP, Agile Map.
• Supplier engagement, Medical Device Industry, 13485/FDA experience.

Culture & Benefits

• Competitive salary, hirify.global Incentive Plan (MIP), 401(k) with match.
• Health, dental, vision insurance, HSA, FSA, life insurance, disability leave.
• Tuition reimbursement, paid time off, holidays, Employee Stock Purchase Plan, EAP.
• Focus on professional growth, cross-functional collaboration, and in-person innovation.