Principal Process Engineer, Advanced Manufacturing Technical Lead (Medical Devices)

Location: Danvers, Massachusetts, United States; onsite a minimum of five days per week

Salary: $128,800–$193,200 per year, plus eligibility for the hirify.global Incentive Plan

Company

hirify.global develops healthcare technologies designed to alleviate pain, restore health, and extend life, serving patients across more than 150 countries.

What you will do

• Provide hands-on technical leadership across process development, equipment selection and integration, process characterization, validation, technology transfer, and manufacturing optimization.
• Lead complex engineering initiatives from concept through implementation while balancing quality, manufacturability, scalability, cost, and timelines.
• Evaluate materials, tooling, equipment, process parameters, product design, automation, and digital manufacturing technologies.
• Partner with R&D, Quality, Operations, Supply Chain, Regulatory Affairs, and external partners to resolve technical challenges and support new product introductions.
• Establish process controls and validation strategies using DOE, SPC, capability analysis, risk assessments, and IQ/OQ/PQ activities.
• Investigate manufacturing issues, implement sustainable corrective and preventive actions, mentor engineers, and contribute to technology roadmaps and capital planning.

Requirements

• Bachelor’s degree and at least 7 years of relevant experience, or an advanced degree and at least 5 years of relevant experience.
• Broad hands-on engineering experience across manufacturing processes, equipment, materials, validation, production support, and continuous improvement.
• Experience with process validation, FMEA, statistical analysis, DOE, SPC, and process capability.
• Strong technical leadership, communication, mentoring, coaching, and cross-functional collaboration skills.
• For degrees earned outside the United States, the degree must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).
• U.S. work authorization sponsorship is available for Principal-level roles and above; the role is based onsite in the United States.

Nice to have

• Experience in medical device, pharmaceutical, biotechnology, or other highly regulated manufacturing environments.
• Experience with plastics processing, injection molding, extrusion, complex assembly, automation, robotics, or equipment integration.
• Design, Reliability, and Manufacturability Green Belt or Black Belt certification or equivalent experience.
• Experience supporting products from development and commercialization through scale-up and ongoing optimization.

Culture & Benefits

• Collaborative, in-person manufacturing environment focused on technical knowledge sharing and professional growth.
• Health, dental, and vision insurance, plus Health Savings and Flexible Spending Accounts.
• Paid time off, paid holidays, short-term and long-term disability coverage, and life insurance.
• 401(k) plan with employer contribution and match, employee stock purchase plan, and incentive plans.
• Tuition assistance, dependent daycare spending account, employee assistance, and global well-being resources.