Senior Biocompatibility Engineer (Medical Devices)

TL;DR

Senior Biocompatibility Engineer (Medical Devices): Evaluating medical device products for biological safety and performing complex risk assessments with an accent on ISO 10993 and 18562 standards. Focus on managing biocompatibility testing, supporting global regulatory submissions, and solving complex biomaterials challenges within an R&D environment.

Location: Must reside within a reasonable commuting distance of Chelmsford, MA. This is a hybrid role and does not offer relocation.

Salary: $116,600–$130,000

Company

hirify.global Corporation develops innovative lifesaving medical devices and software solutions for EMS, hospital, and military customers globally.

What you will do

• Perform complex biological risk assessments for new products and manufacturing changes.
• Ensure testing meets international standards including ISO, FDA, and EU MDR requirements.
• Create and defend biocompatibility documentation for global regulatory submissions.
• Collaborate with internal R&D teams and external testing labs to execute risk assessments.
• Support regulatory authority audits regarding biocompatibility compliance.
• Manage assessment documentation within the electronic document control system.

Requirements

• Must be authorized to work in the US without sponsorship (no H1B, TN, STEM, OPT, etc.).
• Bachelor’s or Master’s degree in biomedical engineering, materials science, polymer chemistry, or analytical chemistry.
• 5+ years of medical device biocompatibility experience or a PhD in a relevant field.
• Expertise in ISO 10993 and ISO 18562 standards.
• Ability to work on-site in Chelmsford, MA.
• Strong project management and cross-functional communication skills.

Culture & Benefits

• Comprehensive benefits package including health, dental, and vision plans.
• Opportunity to work on lifesaving medical technology.
• Collaborative and innovative work environment.
• Annual bonus eligibility based on company performance.