Senior Manufacturing Extrusion Engineer (Medtech)

TL;DR

Senior Manufacturing Extrusion Engineer (Medtech): Supporting daily operations and driving efficiencies in extrusion processes to deliver cost savings for life-saving medical devices with an accent on materials science and manufacturing engineering. Focus on optimizing extrusion processes, implementing equipment qualifications (IQ/OQ/PQ), and ensuring strict compliance with regulatory policies.

Location: Fully onsite in Danvers, Massachusetts, USA (5 days a week)

Salary: $102,400 - $153,600

Company

Global healthcare technology leader dedicated to alleviating pain, restoring health, and extending life through engineering innovation.

What you will do

• Manage individual project schedules and lead cross-functional teams to drive continuous improvements.
• Order, implement, and qualify extrusion equipment and tooling.
• Execute process and equipment validations through Installation Qualification, Operational Qualification, and Process Qualification (IQ, OQ, PQ).
• Perform root cause investigations and implement corrective actions for Non Conformance Reports.
• Author technical specifications and SOPs through the document control system.
• Mentor and provide technical guidance to junior engineers.

Requirements

• Bachelor's Degree with 4+ years of relevant experience OR an Advanced degree with 2+ years of experience.
• Must possess unrestricted U.S. work authorization at the time of hire (Sponsorship is not available for this level).
• Experience with polymer, plastic, or composite extrusion processes, preferably in regulated environments.
• Background in medical device, pharmaceutical, or other highly regulated industries.
• Knowledge of FDA, ISO, and GMP requirements.
• Proficiency in failure analysis techniques and material characterization.

Culture & Benefits

• Comprehensive health, dental, and vision insurance, including HSA and Healthcare Flexible Spending Accounts.
• 401(k) plan with employer contribution and match.
• Short-term incentive via the hirify.global Incentive Plan (MIP).
• Paid time off, paid holidays, and tuition assistance/reimbursement.
• Employee Stock Purchase Plan and a global well-being program (Simple Steps).