Senior Engineer, Design Quality (Medtech)

TL;DR

Senior Engineer, Design Quality (Medtech): Providing design assurance support for medical devices throughout the product lifecycle with an accent on compliance, risk management, and design controls. Focus on collaborating with cross-functional teams to ensure adherence to ISO 13485 and 21 CFR 820 standards during new product development and legacy product remediation.

Location: Must be based in Merrimack, NH, US (Hybrid: 1-2 days remote per week).

Salary: $95,000–$120,000 + 10% STIP.

Company

hirify.global is a global medical technology company providing solutions for intensive care, cardiovascular procedures, and operating rooms to improve clinical results and optimize workflows.

What you will do

• Represent Quality initiatives and compliance on design and development project teams.
• Evaluate design control documentation including requirements, specifications, and FMEAs.
• Own risk management activities in compliance with ISO 14971.
• Provide expertise in evaluating design and process changes for impact on existing deliverables.
• Support CAPA investigations and external regulatory audits.
• Teach and mentor teams on statistical sampling techniques and advanced analysis.

Requirements

• Bachelor’s Degree in Engineering or Science or equivalent experience.
• Minimum of five years of related experience in a medical device environment.
• Firm understanding of Quality System Regulations, ISO 13485, ISO 11607, and ISO 14971.
• Experience with risk management tools such as FMEA and root cause analysis.
• Strong technical writing skills and attention to detail.
• Must be authorized to work in the US and able to work onsite in Merrimack, NH.

Culture & Benefits

• Comprehensive health, dental, and vision insurance.
• 401k plan with company match.
• Paid Time Off and parental/caregiver leave.
• Wellness initiatives and health assistance resources.
• Tuition reimbursement program.
• Short and long-term disability benefits.