Principal Process Engineer

Medtronic Inc.•Northridge, CA

31d

About The Position

This position will play a key role in the development of various new/improved chemistry layers/coatings of glucose sensors by designing and executing design feasibility, process development, and manufacturing transfer. This role will be responsible for driving the product build documentation, design and executing experiments and builds of sensors for pilot scale evaluations, execute data trending & statistical analysis. Upon successful process and design optimization, this role will subsequently support tech transfer to new product introduction and manufacturing teams. You will manage deliverables for multiple projects and maintain an effective system for tracking progress. You will be interfacing with Managers, Engineers &Technicians in R&D and New Product Introduction (NPI) Operations teams as well as Quality and Clinical groups to accomplish day to day activities. The candidate must have strong organizational skills, attention to details, an analytical mindset and ability to communicate effectively with multiple stakeholders. This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.

Requirements

Requires a Baccalaureate degree and minimum of 7 years of relevant experience OR Master's degree with a minimum of 5 years relevant experience OR PhD with 3 years relevant experience.

Nice To Haves

Prior experience with coatings/deposition methodologies including spray, slot, spin, CVD, PVD, as relevant to medical device or semiconductor industries (ex: MEMS photolithography processes)
Standard wet lab techniques as applicable to chemistry or biology labs
Prior experience working in a manufacturing or prototype line in a cleanroom environment in medical device, pharmaceutical or semiconductor industry
Experience with statistical data analysis software (Ex. Minitab, JMP, etc.) and standard statistical tests (T-test, ANOVA)
Experience in programming with MATLAB and/or Python
Performed R&R studies, demonstrating process capability (Ppk & Cpk), and Qualification procedures (IQ/OQ/PQ)
Exposure to Design for Reliability and Manufacturability (DRM) principles and/or process and performance improvement tools such as Lean and/or Six Sigma
Experience with technical documentation (Work Instructions, laboratory notebooks, publications, engineering reports, change requests, IQ/OQ/PQ's, Standard Operating Procedures, test protocols, BOMs, DHFs etc.)
Exposure to inventory management and ordering systems (e.g. SAP)
Prior project management experience
Ability to collaborate with multiple departments to analyze and assess Non-conformances and mitigate risk by following established procedures.
Demonstrated written and verbal communication skills
Ability to manage multiple tasks & projects and work independently & within a team-based environment
Experience with quality documentation and systems (e.g. Agile PLM.)

Responsibilities

Develop & utilize technical & wet lab skills associated with medical device coatings/deposition & relevant fabrication processes
Utilize design of experiments (DOEs), statistical process control, and statistical data analysis methodologies in developing new designs and processes to integrate with next generation sensors
Generate documentation following good documentation practices in relation to product builds & instructions, clinical documentation, specifications, etc. and drive approvals
Act as a key interface with Manufacturing/Production teams
Coordinate with material inventory and external or internal vendors in sourcing raw materials and parts for the prototype builds
Develop and support Bill Of Materials (BOM)
Oversee & coordinate device build, sterilization, and testing
Resolve non-compliance issues and inefficiency issues, recommending and implementing process changes.
Provides technical support to device failure analysis on devices
Attend prototype product build coordination meetings, including schedule management; gather and verify requirements and communicate updates to stakeholders in a timely manner
Utilize knowledge of project management, schedules and deliver on day-to-day tasks to accomplish goals for a specific project

Benefits

Medtronic offers a competitive Salary and flexible Benefits Package
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).