Sr. Design Quality Engineer (Medtech)

TL;DR

Sr. Design Quality Engineer (Medtech): Performing quality engineering activities for new product development in the medical device sector with an accent on product risk assessment, mitigation strategies, and design validation. Focus on utilizing DMAIC, Lean Six Sigma, and statistical analysis to ensure robust design and regulatory compliance.

Location: Hybrid in Boston, MA (4 days per week onsite). Relocation assistance is not available.

Salary: $136,600 – $145,200 per year

Company

hirify.global is a global leader in healthcare technology and medical device manufacturing.

What you will do

• Perform quality engineering activities to support new product development (NPD).
• Review requirements and identify/assess product risks and mitigation strategies.
• Conduct engineering analysis to ensure design quality and analyze system and sub-system risks.
• Utilize medical device design controls, product risk files, and Lean Sigma methodologies (DMAIC, DfR, DfM).
• Apply statistical tools including DOE, SPC, ANOVA, and regression analysis for process control.
• Collaborate on predictive complaint analysis and post-market product performance reviews.

Requirements

• Bachelor's degree in Mechanical, Biomedical, or Bio-Engineering (with 5+ years exp) or Master's degree in the same (with 2+ years exp).
• Experience with Medical device design controls, product risk files, and Lean Six Sigma.
• Proficiency in DOE, SPC, ANOVA, and Process Capability analysis.
• Knowledge of FDA 21 CFR Part 820 and ISO 13485.
• Experience with d/p FMECA and ISO 14971.
• Must be based in or able to work onsite in Boston, MA 4 days per week.

Culture & Benefits

• Competitive salary and incentive plans.
• 401(k) plan with employer contribution and match.
• Employee Stock Purchase Plan and Non-qualified Retirement Plan Supplement.
• Paid time off and paid holidays.
• Comprehensive health benefits including short-term disability and Employee Assistance Program.