The Opportunity That Awaits You: Are you ready to build the equipment, automation, and engineering capabilities behind the next generation of surgical technology? This is an opportunity to establish and lead a high-performing equipment engineering team responsible for designing, qualifying, and deploying the manufacturing and test systems used to produce innovative surgical capital equipment. You will define the equipment and automation strategy, establish engineering and validation standards, and collaborate with R&D, NPI, Operations, and external suppliers to bring robust solutions from concept through IQ/OQ/PQ and production release. Your leadership will directly improve manufacturing yield, test coverage, diagnostic capability, productivity, and error-proofing while ensuring compliance with GMP and other medical-device requirements. We are looking for an experienced, hands-on engineering leader who combines deep technical expertise with strong cross-functional leadership and is excited to build a team, solve complex equipment challenges, and help shape the future of our manufacturing operations.
What Your Day-To-Day Will Involve:- Establish and lead a team to design and build equipment for use in manufacturing and testing of surgical capital equipment
- Lead a team through continuous improvements and project executions and periodically report key metrics on the team's performance.
- develop and deploy solutions.
- Work with the R&D and NPI teams to identify and incorporate design for test optimizations.
- Facilitate communication and interaction among cross functional team members to ensure adherence to critical deliverables and milestones.
- Develop relationships with external automation and tooling suppliers to increase capacity to
- Establish standards for equipment design, performance, validation and maintenance.
- Plan and execute test method and test equipment validations.
- Write specifications for test equipment and leverage external partners to build and validate the equipment
- Oversee product test specifications and applicable test equipment requirements for new products.
- Maintain BOMs for test fixtures, tools, or aids. Maintain spare equipment, hardware/software, and computer configurations.
- Determine the root cause of equipment and system test failures.
- Develop and execute equipment/automation strategy in support of overall Operations strategy.
- Identify, design, qualify, document, and implement automation test and assembly equipment solutions to be used in manufacturing.
- Document all aspects of the equipment, including its requirements, design, operation, and qualification in compliance with Good Manufacturing Processes (GMP).
- Perform design reviews for new equipment and tooling developed.
- Execute equipment design and process verification/validation, including IQ/OQ/PQ activities to allow production release of new equipment.
- Drive continuous improvement projects to increase manufacturing yields, improve test coverage, diagnostic capability, productivity, and error proofing.
- Utilize statistical tools to develop reports of process performance and identify areas of manufacturing improvement
- Draft and execute factory acceptance testing(FAT)
- Establish design requirements and specifications for automated testing
The Qualifications We Need You to Possess- Bachelor of Science of electrical, mechanical or software engineering
- Minimum 7 years' experience in Medical Device manufacturing
- Prior hands-on Equipment Engineering experience supporting manufacturing.
- Experience working in a medical device company or other regulated business.
- Strong organizational skills, detail oriented. Exceptional oral and written communication skills.
- Demonstrated leadership skills in building cross-functional collaboration including conflict resolution, assertiveness, and negotiation skills.
- Support onsite for 5 days in person
The Qualifications We Would Like You to Possess - Experience driving a team using Scrum Agile framework
- Demonstrated understanding of FDA Quality System Regulation (21 CFR 820) and ISO 13485.
- Knowledge of computer software for the analysis of data, specifically Microsoft Excel and statistical packages (Minitab preferred)
Pay Range for this role:
$164,500 to $193,530
