Manufacturing Mechanical Engineer II (MedTech)

Location: Onsite in Waltham, Massachusetts, United States

Salary: $90,000–$105,000 per year

Company

hirify.global develops instruments, consumables, and in vitro diagnostic solutions for biopharmaceutical and clinical applications. The company operates FDA-registered, ISO-certified manufacturing and serves customers in more than 100 countries.

What you will do

• Provide day-to-day technical support for reagent, sensor, tubing, and other consumable manufacturing operations.
• Investigate manufacturing and product-processing issues, test consumables, inspect components, and support disposition of nonconforming products.
• Create and maintain regulated manufacturing documentation, including procedures, drawings, artwork, and manufacturing variances.
• Execute qualification, validation, design of experiments, PFMEA, and continuous improvement activities.
• Specify and procure equipment, design tooling and fixtures, modify production equipment, and support new product and process transfers.
• Train operators, collaborate with engineering, quality, manufacturing, and business teams, and mentor co-op students and interns.

Requirements

• Bachelor of Science degree in Mechanical Engineering or Manufacturing Engineering.
• Three or more years of relevant engineering experience is desired, including hands-on support in a manufacturing environment.
• Advanced proficiency with Microsoft Office, Minitab, SAP, and MasterControl; basic proficiency with SolidWorks.
• Knowledge of FDA Quality System Regulations and ISO standards, with experience creating regulated documentation and supporting IQ, OQ, PQ, DOE, and PFMEA activities.
• Experience with equipment procurement, tooling and fixture design, production equipment modification, process transfers, lean manufacturing, and continuous improvement.
• Ability to work onsite in Waltham, Massachusetts, and perform physical manufacturing duties, including standing, walking, repetitive tasks, bending, reaching, and lifting up to 25–50 pounds.

Culture & Benefits

• Medical, dental, and vision coverage.
• Competitive 401(k) company match and bonus program.
• Generous paid time off, paid holidays, and tuition reimbursement.
• Professional development, engagement, and company events.
• Subsidized food benefits at company offices, including the Waltham cafeteria.
• Collaborative culture focused on customer centricity, ingenuity, accountability, collaboration, and integrity.