Senior Orthopedic Design Controls 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® 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.