Zimmer Biomet
Development Staff Engineer – Zimmer Biomet
At Zimmer Biomet, a global medical technology leader for nearly 100 years, we push the boundaries of innovation to enhance patient mobility every 8 seconds. As a team member, you will share our commitment to providing mobility and renewed life to people worldwide. We focus on development opportunities, robust employee resource groups, a flexible working environment, competitive total rewards, wellness incentives, and a culture of recognition and performance awards. Our vision is to create an inclusive, respectful, empowered, and recognized environment.
What You Can Expect Monogram, a Zimmer Biomet Company, is hiring a Staff Development Engineer in Austin, Texas. Our surgeon‑guided semi‑ and fully autonomous robotic technologies bring new capabilities to our suite of patient‑centric solutions. By joining this team, you will work on cutting‑edge technology that improves patient outcomes and relieves pain worldwide.
Responsibilities
Technical Leadership :
Serve as the subject matter expert for one or more core technologies or product lines.
Lead complex design and development activities from concept through design transfer and manufacturing.
Develop and maintain design control documentation (design inputs, risk analysis, verification/validation protocols).
Innovation & Design :
Generate and evaluate innovative solutions to complex engineering challenges.
Apply engineering principles, modeling, and simulation tools to develop safe, effective, and reliable devices.
Support feasibility studies, prototyping, and design optimization.
Cross‑Functional Collaboration :
Partner with Quality, Regulatory, and Clinical teams to ensure design compliance with FDA, ISO 13485, and other global regulatory standards.
Work closely with suppliers and manufacturing partners to ensure design‑formanufacturability and scalability.
Technical Strategy & Mentorship :
Provide technical guidance and mentorship to junior engineers and project teams.
Contribute to the long‑term technology roadmap and identify opportunities for product and process improvements.
Lead technical reviews and participate in design and risk assessments.
Compliance & Quality :
Ensure adherence to design control, risk management, and change control procedures per ISO 14971 and 21 CFR Part 820.
Support root‑cause investigations and CAPA activities for field or production issues.
Lead verification and validation activities such as drafting protocols, executing protocols, and drafting reports.
Qualifications
Master’s or PhD in Engineering or a related field.
Experience with Class II or Class III implantable or electromechanical devices.
Knowledge of biocompatibility, sterilization, and validation processes.
Familiarity with Agile development and systems engineering practices.
Demonstrated leadership and mentoring experience.
Strong problem‑solving and analytical thinking.
Excellent communication and collaboration skills.
Ability to operate effectively in a fast‑paced, cross‑functional environment.
Commitment to patient safety, product quality, and regulatory compliance.
Strategic and systems‑level thinking.
Background & Experience
Bachelor’s degree in Mechanical, Electrical, Biomedical, or related Engineering discipline.
8+ years of engineering experience in the medical device or other regulated industry.
Proven track record of leading technical projects through the full product lifecycle.
Strong understanding of design controls, risk management, and regulatory compliance (FDA, ISO 13485, ISO 14971).
Proficiency with CAD, FEA, or equivalent engineering design and analysis tools.
Physical & Travel Requirements
Physical requirements: None specified.
Travel expectations: Up to 20%.
Equal Opportunity Employment We’re an equal opportunity employer: EOE/M/F/Vet/Disability.
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What You Can Expect Monogram, a Zimmer Biomet Company, is hiring a Staff Development Engineer in Austin, Texas. Our surgeon‑guided semi‑ and fully autonomous robotic technologies bring new capabilities to our suite of patient‑centric solutions. By joining this team, you will work on cutting‑edge technology that improves patient outcomes and relieves pain worldwide.
Responsibilities
Technical Leadership :
Serve as the subject matter expert for one or more core technologies or product lines.
Lead complex design and development activities from concept through design transfer and manufacturing.
Develop and maintain design control documentation (design inputs, risk analysis, verification/validation protocols).
Innovation & Design :
Generate and evaluate innovative solutions to complex engineering challenges.
Apply engineering principles, modeling, and simulation tools to develop safe, effective, and reliable devices.
Support feasibility studies, prototyping, and design optimization.
Cross‑Functional Collaboration :
Partner with Quality, Regulatory, and Clinical teams to ensure design compliance with FDA, ISO 13485, and other global regulatory standards.
Work closely with suppliers and manufacturing partners to ensure design‑formanufacturability and scalability.
Technical Strategy & Mentorship :
Provide technical guidance and mentorship to junior engineers and project teams.
Contribute to the long‑term technology roadmap and identify opportunities for product and process improvements.
Lead technical reviews and participate in design and risk assessments.
Compliance & Quality :
Ensure adherence to design control, risk management, and change control procedures per ISO 14971 and 21 CFR Part 820.
Support root‑cause investigations and CAPA activities for field or production issues.
Lead verification and validation activities such as drafting protocols, executing protocols, and drafting reports.
Qualifications
Master’s or PhD in Engineering or a related field.
Experience with Class II or Class III implantable or electromechanical devices.
Knowledge of biocompatibility, sterilization, and validation processes.
Familiarity with Agile development and systems engineering practices.
Demonstrated leadership and mentoring experience.
Strong problem‑solving and analytical thinking.
Excellent communication and collaboration skills.
Ability to operate effectively in a fast‑paced, cross‑functional environment.
Commitment to patient safety, product quality, and regulatory compliance.
Strategic and systems‑level thinking.
Background & Experience
Bachelor’s degree in Mechanical, Electrical, Biomedical, or related Engineering discipline.
8+ years of engineering experience in the medical device or other regulated industry.
Proven track record of leading technical projects through the full product lifecycle.
Strong understanding of design controls, risk management, and regulatory compliance (FDA, ISO 13485, ISO 14971).
Proficiency with CAD, FEA, or equivalent engineering design and analysis tools.
Physical & Travel Requirements
Physical requirements: None specified.
Travel expectations: Up to 20%.
Equal Opportunity Employment We’re an equal opportunity employer: EOE/M/F/Vet/Disability.
#J-18808-Ljbffr