Principal Manufacturing Engineer Job Highlights
|Title||Principal Manufacturing Engineer|
|Location||Boulder, CO, United States|
Medtronic is a global healthcare technology leader boldly attacking the most challenging health problems facing humanity with innovations that transform lives.
The company is hiring a Principal Manufacturing Engineer who will be proficient in complex electromechanical products and manufacturing operations and who excels in leadership behaviors.
Also, responsible for Operations support and Engineering project leadership related to Medtronic Finished Good products and processes at Contract Manufacturing (CM) sites and for products procured from OEM suppliers globally.
Collaborate with Operations & OU Quality, Released Product Engineering, Supply Planning, Supply Management, and the CM/OEMs to ensure quality excellence, continuity of supply, and execution of all identified project objectives in a dynamic multi-project and priority-changing environment
- Applicants should have a Bachelor’s Degree in Engineering or a related degree from a college or university
- 7+ years of experience with a Bachelor’s Degree OR 5+ years of experience with an Advanced Degree
- Possess a combination of education and work experience
- Conduct, coordinate, and provide support in formal Process Validations including protocol development and execution.
- Consistently deliver proactive, high-quality manufacturing & service technical support and guidance to Contract Manufacturers for engineering issues.
- Designs and sustains manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, machining, and material handling
- Ensure adherence to product specifications, industry standards, and quality and regulatory procedures and requirements.
- Ensures processes and procedures are in compliance with regulations
- Establish process and equipment performance metrics, monitor performance trends, and maintain and improve manufacturing efficiency.
- Initiate and execute continuous improvement activities to improve product quality and reduce manufacturing process cycle time
- Lead and support Quality and Engineering initiatives at CM’s
- Manage all technical aspects of the Change Management processes in the Contract Manufacturing organization.
- Manage BOMs and DMR for sustaining manufacturing
- Manage change orders affecting products and process for implementation at our contract manufacturers
- Manage technical aspects of product and process at Contract Manufacturing & OEM partners.
- Participate as SME in FDA inspections, ISO Certifications, and internal and external customer audits.
- Participate in product design review and ensure design for manufacturability and all requirement specifications are met
- Provide guidance to Contract Manufacturers in the designs and evaluate new and existing fixtures and equipment, test methods, specifications, layouts, and standards supporting a Lean manufacturing environment.
- Provide inputs to the MDT Supplier Change Request (SCR) Board process
- Provide technical support and guidance to colleagues and peers in RPE, R&D, and other functions about working with CM and OEM partners.
- Resolve emergent technical issues, provide troubleshooting, failure (root cause) analysis, and provide permanent solutions
- Responsible for on-time product delivery, quality, and cost
- Specify, procure, and manage capital in the support of manufacturing and test processes.
- Support the development of multi-year capital procurement plans
- Sustain contract manufacturing processes, testers, fixtures, and equipment
- Work as a liaison with the Contract Manufacturer and MDT to ensure Design for Manufacturing (DFM) elements are incorporated to improve yield.
Nice to Have
- 10+ years of Manufacturing Engineering experience or equivalent
- 5+ years of experience working in a regulated industry
- Ability to deal with ambiguity and pivot quickly to meet changing business priorities
- Ability to understand and operate within a complex, global matrixed organization
- Comfortable engaging with leadership/Exec level personnel
- Demonstrate flexibility, adaptability, and integrity when making decisions, adopting a risk-based approach
- Demonstrated ability to interact and collaborate with all levels of the organization and external stakeholders including Contract Manufacturers
- Demonstrated application of the Medtronic Mindset (5 Culture Norms)
- Demonstrated understanding and application of financial planning and analysis. Strong Business Acumen and understanding of operations and commercial financial drivers
- Detailed understanding of Change Management Processes and Procedures. Experience with Agile PLM is an advantage
- Electrical engineering degree or relevant experience with complex electromechanical products, test systems, and solutions – ability to interact and partner with electrical and system design engineers
- Experience leading global project teams and operating effectively in a virtual workspace
- Experience with Contract Manufacturing (preferred but not mandatory)
- Experience with ERP/MRP or SAP and Agile PLM experience is preferred.
- Experience with operations processes including supply planning, capacity planning, sourcing
- Familiar with electromechanical manufacturing processes, including PLC programming, adhesive dispensing, fastening methods, laser or resistance welding, ultrasonic welding, vision systems, and test systems using LabView software.
- Familiarity with OEE and other Key Performance Indicators, Maintenance, and Reliability
- Lean manufacturing/Six Sigma concepts and understanding.
- Process Verification and Validation knowledge.
- Project Management Qualification or Training
- Proven track record of successful influence without authority where both collaboration and persuasion of cross-functional stakeholders were critical
- Working knowledge of global Quality System requirements, Medical Device manufacturing, knowledge of ISO 13485/FDA requirements
- Clear communicator with excellent written and verbal presentation skills
- Results Driven, Accountable, Say-Do attitude, Ambitious, Career-development mindset
- Self-directed with the ability to develop, facilitate and gain consensus in a team environment.
- Travel may be required for up to 25%
- Strong analytical and data-driven approach with proven problem-solving capabilities
Medtronic is an Equal Opportunity Employer and considers all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law.
To apply for this job please visit medtronic.eightfold.ai.