Sr. Engineer, Product (Medtech)

TL;DR

Sr. Engineer, Product (Medtech): Delivering engineering solutions to sustain production of implantable and consumable medical devices with an accent on design and supplier changes, CAPAs, and compliance. Focus on leading cross-functional teams to improve product performance, reduce costs, and ensure adherence to medical device regulations.

Location: Merrimack, NH, US (Hybrid: 1-2 days at home)

Salary: $95,000 – $120,000 + 10% STIP

Company

hirify.global provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows across intensive care and cardiovascular procedures.

What you will do

• Lead design change projects to improve product performance, reduce costs, and enhance manufacturability.
• Manage CAPAs, NCRs, and Product Complaints by investigating and addressing potential design issues.
• Conduct Design Reviews to evaluate the adequacy of requirements and resolve technical problems.
• Create and execute protocols for Design Verification and Validation, engineering studies, and feasibility studies.
• Maintain the Design History File (DHF) and Device Master Record (DMR) throughout the product lifecycle.
• Mentor junior staff and provide project status updates to management.

Requirements

• Bachelor’s degree in Engineering or a scientific discipline (Chemical, Biomedical, Materials, or Mechanical).
• Minimum 5 years of experience in the medical device industry or other regulated industry.
• Relevant experience in design controls, production/process controls, and R&D.
• Knowledge of 21 CFR Part 820 and other standards relevant to medical devices.
• Proven experience leading cross-functional project teams as a decision-maker.

Nice to have

• Experience with Agile PLM and Minitab.

Culture & Benefits

• Comprehensive Health, Dental, and Vision insurance.
• 401k plan with company match.
• Paid Time Off and Wellness initiative resources.
• Life Insurance, Short and Long Term Disability.
• Health and Dependent Care Flexible Spending Accounts.
• Parental and Caregiver Leave and Tuition Reimbursement.