Senior Fire Protection Engineer

TekWissen ®; Warsaw (IN); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Equal opportunity employer supporting全

Job summary

TekWissen® Group seeks an engineering professional to align design controls and risk management for orthopedic medical devices. You will drive integration efforts, author remediation plans, and support regulatory documentation with cross-functional teams.

Ideal candidates bring a bachelor’s in engineering, 3+ years in regulated medical device product development, and familiarity with ISO 13485, ISO 14971, and 21 CFR Part 820. Minitab skills and DOE experience are pluses.

Qualifications

• Bachelors in Engineering with 3+ years in regulated medical device development.
• ABET-accredited degree preferred in Mechanical/Biomedical disciplines.
• Experience with orthopedic implants, medical software, or biomaterials is highly valued.

Responsibilities

• Harmonizes design controls and risk management with global processes.
• Supports integration by authoring remediation protocols for acquisitions.
• Raises decisions on integration strategy in projects with supervision.
• Acts as technical lead or PM for feasible, lower-complexity projects.
• Plans deliverables, timelines, budgets, and risks for stakeholders.
• Reviews site documentation for gaps; applies infection prevention knowledge.
• Coordinates cross-functional deliverables with partners.
• Develops product and process specs, identifies CTQ attributes.
• Authors and secures cross-functional approvals for regulatory docs.

Skills

Technical communication

Procedures writing

Medical device standards

Drug-device understanding

Statistics & DOE

Minitab

Education

Bachelor's in Engineering

ABET-accredited preferred

Tools

Minitab

Job description

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Client designs, develops, manufactures and markets orthopedics products, including knee, hip, shoulder, elbow, foot and ankle artificial joints and dental prostheses. client has operations in more than 40 countries around the world.

Expected Job Duties

• Harmonizes design controls and risk management procedures from a new acquisition with the global design controls and risk management processes at Client.
• Supports integration activities by authoring remediation protocols and assisting the team reaching the correct decisions on integration strategy.
• May serve as technical lead or project manager for feasibility workstreams and small-scale, lower-complexity projects involving new product development, technology integration, design changes, or manufacturing/sourcing transfers under appropriate supervision.
• Creates and communicates project plans, timelines, budgets, resource needs, technical deliverables, decision criteria, risks, contingency plans, and status updates to stakeholders and leadership.
• Applies understanding of orthopedic infection prevention and treatment practices, clinical workflows, product intended use, and applicable regulations to support review of site documentation to identify any gaps or opportunities for improvement with guidance from technical and cross-functional leaders.
• Plans and coordinates deliverables with cross-functional teams and external partners.
• Develops product and process specifications, identifies critical-to-quality attributes, and supports quality control strategies based on intended use, design requirements, material and biological performance, infection-relevant performance attributes, and user risks.
• Authors, reviews, and obtains cross-functional approval of design control, risk management, regulatory, and evidence-supporting documentation, including materials for regulatory activities associated with the integration.
• This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

Skills:

• Demonstrated strong written and verbal communication skills, with the ability to communicate technical information to cross-functional and global audiences.
• Specifically, experience writing procedures, protocols, and technical rationales is preferred.
• Working knowledge and familiarity with the following Medical Device Standards / Regulations: 21 CFR Part 820 QSR (2024), ISO 13485, ISO 14971, MDD, MDR, IEC 62366-1, ISO/IEC 27001, BS EN 62304.
• Familiarity with drug-device combination products and software as a medical device is preferred.
• Demonstrated working knowledge of statistics applied to engineering studies, including sample size rationale, design of experiments, and hypothesis testing; Minitab experience desired.

Education:

• Minimum Requirements: Bachelor's Degree in Engineering and 3 years of relevant experience or equivalent experience.
• Degree from an ABET-accredited school (or global equivalent) in Mechanical Engineering, Biomedical Engineering, Bioengineering, Materials Science or Materials Engineering, Chemical Engineering, Polymer Engineering, or a related engineering discipline highly preferred.
• 3-5 years of full-time engineering experience in regulated medical device product development highly preferred.
• Experience with orthopedic implants, medical software, biomaterials, antimicrobial technologies, wound management, coatings, or local drug delivery is strongly preferred.

TekWissen® Group is an equal opportunity employer supporting workforce diversity.