Engineer II, Product (Medtech)

TL;DR

Engineer II, Product (Medtech): Delivering engineering solutions to sustain production of implantable and consumable medical devices with an accent on design changes, compliance, and supplier management. Focus on solving technical challenges via CAPAs, NCRs, and executing design verification and validation protocols.

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

Salary: $90,000–$110,000 + 8% STI

Company

hirify.global provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows.

What you will do

• Initiate design change projects to improve product performance, reduce costs, and enhance manufacturability.
• Support CAPAs, NCRs, and product complaints by investigating and addressing potential design issues.
• Collaborate with current and prospective suppliers on changes to purchased components.
• Create and execute protocols for Design Verification and Validation, engineering studies, and equipment qualification.
• Maintain the Design History File (DHF) and Device Master Record (DMR) throughout the product lifecycle.
• Participate in Design Reviews to evaluate requirements and resolve technical problems.

Requirements

• Bachelor’s degree in Engineering or scientific discipline (chemical, biomedical, materials, or mechanical).
• Minimum 2 years’ experience in the medical device or other regulated industry.
• Relevant experience in design controls, production and process controls, or R&D.
• Knowledge of 21 CFR Part 820 and medical device standards.
• Proficiency in Microsoft Office applications.
• Knowledge of Good Documentation Practices (GDP).

Nice to have

• Experience with Agile PLM.
• Experience with Minitab.

Culture & Benefits

• Comprehensive Health, Dental, and Vision insurance.
• 401k plan with company match.
• Paid Time Off and Parental/Caregiver Leave.
• Tuition Reimbursement and wellness initiatives.
• Health and Dependent Care Flexible Spending Accounts.
• Commuter Benefits.