Job Summary

• Leverage cross functional groups to evaluate, develop and coordinate projects for new product development and ongoing lifecycle management of products, processes and therapies.
• Conduct, coordinate and aid in formal Process Validations Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), Gage R&R and Test Method validations (TMV), DOE (Design of Experiments) and PPAPs.
• The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Matching Summary

Salary

Base: $120,000 to $150,000 per year; Bonus/Equity: Incentive plans; Benefits: 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement, Capital Accumulation Plan

Skills & Requirements

Key Requirements

• Master's Degree or Bachelor's Degree in Engineering
• 2 years project/manufacturing engineer experience
• 5 years project/manufacturing engineer experience
• MS Project and Project Online experience
• FDA QSR, EU MDR, 21 CFR Part 820, ISO 13485, ISO 14971 experience
• IQ, OQ, PQ, Gage R&R, TMV, DOE, PPAPs experience
• DFMA, DFMEA, PFMEA experience
• Lean and Six Sigma experience
• GMP and GDP experience
• FDA 510(k) Regulatory Submission experience
• AGILE (QMS) and ERP system experience

Work Rights