About the position
Principal Process Engineer for Medtronic, Inc. located in Santa Ana, CA. Multiple positions available. Work within the Process Development group and collaborate with R&D and Design Assurance to bridge concept to commercialization gap for products in the development pipeline; act as the technical contributor and coordinator for the design and development of manufacturing processes for new and iterative heart valve therapies from concept through design transfer and product launch; coordinate process technology implementation into pilot manufacturing and commercial lines where applicable; conduct exploration and development of new process technologies for tissue processing and valve manufacturing; support new product development by designing and developing pilot manufacturing processes, including equipment/fixture/tooling and process characterization and specification development, as well as executing engineering builds for design validation (DV), clinical studies and regulatory submissions; coordinate and execute design & manufacturing transfer of pilot line to commercial production per Operations transfer strategy and Manufacturing Validation Plan (MVP), including installation qualification, operational qualification, and performance qualification, and Test Method Validation (IQ/OQ/PQ/TMV), manufacturing documentation, process risk mgmt. & failure mode and effect analysis (FMEA), and product/process support via operator/engineering training, trouble-shooting/root cause investigation (RCI); utilize tools and concepts in Design for Reliability and Manufacturability (DRM) and Lean Six Sigma, such as requirements flow down, Design of Experiment (DOE), Measurements System Analysis (MSA), Statistical Process Control (SPC), predictive modeling, correlation studies, Minitab Hypothesis Testing, and Process Capability Studies to advance manufacturing quality and reliability; utilize SOLIDWORKS for tooling and fixture development and concept development for process automation; work in ISO Class 7 and 8 cleanrooms for implantable medical devices; employ project mgmt. methodologies and tools to ensure timely completion of project deliverables and efficient allocation of resources, such as mgmt. of project plans/contracts, schedules, and project budget, as well as utilization of data visualization techniques through software programs (i.e. Power BI) to effectively communicate project progress and financial performance to stakeholders and negotiate for resources as needed; navigate the complexities of ISO standards for product/process design and development, including ISO 13485, ISO 5840, and ISO 14971, as well as regulatory requirements per FDA 21 CFR (US), Medical Device Directive (MDD) & Medical Device Regulations (MDR) (EU), Pharmaceuticals and Medical Device Agency (PMDA) (Japan), and Therapeutics Products Directorate (TPD) (Canada). *Position works a hybrid model and will be onsite in Santa Ana, CA four (4) days per week. Relocation assistance not provided. #LI-DNI.
Responsibilities
- Collaborate with R&D and Design Assurance to bridge concept to commercialization gap for products in the development pipeline.
- Act as the technical contributor and coordinator for the design and development of manufacturing processes for new and iterative heart valve therapies.
- Coordinate process technology implementation into pilot manufacturing and commercial lines.
- Conduct exploration and development of new process technologies for tissue processing and valve manufacturing.
- Support new product development by designing and developing pilot manufacturing processes.
- Execute engineering builds for design validation (DV), clinical studies, and regulatory submissions.
- Coordinate and execute design & manufacturing transfer of pilot line to commercial production.
- Utilize tools and concepts in Design for Reliability and Manufacturability (DRM) and Lean Six Sigma.
- Utilize SOLIDWORKS for tooling and fixture development and concept development for process automation.
- Work in ISO Class 7 and 8 cleanrooms for implantable medical devices.
- Employ project management methodologies and tools to ensure timely completion of project deliverables.
- Navigate the complexities of ISO standards for product/process design and development.
Requirements
- Bachelors' Degree or foreign equivalent in Mechanical, Industrial, or Biomedical Engineering or related engineering field.
- Five (5) years of progressive post-baccalaureate experience as a process or manufacturing engineer or related occupation for medical devices.
- Experience with developing process technologies for tissue processing and valve manufacturing.
- Experience in design and development of pilot manufacturing processes, utilizing DRM, Lean Six Sigma, requirements flow down, DOE, MSA, SPC, predictive modeling, correlation studies, Minitab Hypothesis Testing, Process Capability Studies, and SOLIDWORKS.
- Experience executing engineering builds for DV, clinical studies, and regulatory submissions.
- Experience in design & manufacturing transfer of pilot line, including IQ/OQ/PQ/TMV, Process Risk Management & FMEA.
- Experience in project contracts/planning, operational budget, data visualization for stakeholders, and financial reports and resource negotiation.
- Knowledge of ISO 13485, ISO 5840, and ISO 14971 standards and FDA 21 CFR, MDD or MDR (EU), PMDA (Japan), and TPD (Canada).
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
