Principal Manufacturing Engineer (Medical Devices)

Location: Jacksonville, Florida, United States of America. Relocation assistance is not available.

Salary: $144,000–$184,800 per year.

Company

hirify.global develops and manufactures medical devices and operates regulated manufacturing and supplier-transfer programs.

What you will do

• Coordinate and execute site Verification and Validation (V&V) deliverables for supplier transfers within the Supplier Optimization group and Transfer Office.
• Assist with defining Quality Impact Levels for supplier-qualified products and manage PPAP activities for supplier-provided goods.
• Design assembly and holding fixtures, coordinate supplier fabrication, and develop protocols, reports, process instructions, preventive-maintenance plans, and calibration schedules.
• Create and approve V&V protocols and reports covering top-level assembly and sub-assembly acceptance criteria, criticality-based sample sizes, and sampling plans.
• Use IQ, OQ, PQ, Minitab, TMV, capability analysis, tolerance intervals, and SPC for qualification and process validation.
• Maintain Control Plans, Process Flow Maps, PFMEA, BOM structures, QMS records, and First Article Inspection results using AGILE, SAP, and ERP systems.

Requirements

• Master’s degree in Mechanical, Industrial, Biomedical, or related Engineering plus five years of manufacturing or design engineering experience in medical devices; or Bachelor’s degree in the same fields plus seven years of such experience.
• At least five years of experience with FDA 21 CFR Part 820, EU MDR, ISO 13485, ISO 14971, and GMP.
• At least five years of experience with PPAP and IQ/OQ/PQ.
• At least five years of experience with Minitab, TMV, capability analysis including Ppk and tolerance intervals, and SPC.
• At least five years of experience creating Control Plans, Process Flow Maps, and PFMEA.
• At least five years of experience creating and approving V&V protocols and reports, including assembly and sub-assembly test acceptance criteria, criticality-based sample sizes, and sampling plans.
• At least five years of experience with AGILE, SAP, and ERP systems.
• At least five years of experience executing First Article Inspection activities and summation of results.
• At least five years of experience updating BOM structures within a QMS.

Culture & Benefits

• Full-time regular employment with health, dental, and vision insurance for eligible employees working 20 or more hours per week.
• Access to Health Savings and Flexible Spending Accounts, life insurance, disability coverage, dependent-care spending accounts, and tuition assistance for eligible employees.
• Incentive plans, 401(k) with employer contribution and match, paid time off, and paid holidays for regular employees.
• Additional programs include an Employee Stock Purchase Plan, Employee Assistance Program, and retirement-plan supplements subject to eligibility requirements.