Sr. Principal Mechanical Process Development Engineer (Northridge, CA)

Careers That Change Lives

As a member of the Mechanical Engineering R&D group, the individual selected for this role will lead new product design activities of products such as insulin pumps, glucose sensors, and related accessories. They will work at the intersection of product design and process development, optimizing for customer and business needs.

The ideal candidate for this position has had extensive experience in new product and process development, design, verification, and validation. Experience in plastics and electromechanical assemblies in the medical device industry a plus. The ideal candidate has a strong background in process design, development and qualification including Test Method Validation (TMV) as well as hands-on prototyping/testing. This individual is experienced in problem solving and performing data analysis using statistical methods and tools (DOE, Regression, ANOVA, Capability Analysis, GR&R). Self-Starter and a technical leader with a sharp focus on quality and customer experience. This position will work across the organization driving and collaborating with functions in R&D, Operations, PMO, Quality and Regulatory to assure the successful execution of business goals.

We are a learning culture. An inventive and collaborative group. We are dedicated to making sure that every patient gets the best product - when they need it. We have strong ties to our local communities. Our vibrant employee communities respect and value individual experience and perspective as we aim to improve lives and the access to healthcare. #ReferMDTDiabetes

Job duties to be primarily located on-site in Northridge, CA with the ability to work limited hours remotely.

A Day in the Life

• Drive and lead product and process development activities of complex medical products by identifying key process inputs, outputs, controls, and noise factors by effective utilization of Six Sigma tools

• Drive and lead design transfer activities ensuring product is transitioned to manufacturing facility successfully

• Apply methodologies such as Design for Reliability and Manufacturing (DRM), Design for Six Sigma (DFSS), Design for Manufacturing Assembly / Automation (DFM/A) during process design and development phase

• Lead and perform process characterization, design verification / testing, and Test Method Validation (TMV) activities

• Apply Six Sigma (DFSS) methodologies to all aspects of the design / development process

• Perform Statistical analysis (DOE, Regression, ANOVA, Capability Analysis, GR&R)

• Help with equipment selection, tooling and fixture development, procurement, installation, and qualification.

• Drive corrective and preventive actions with appropriate and detailed follow up

• Provide guidance and mentorship to junior engineering staff

• Help develop specifications, test methodologies, and test equipment to evaluate design concepts

• Perform calculations, analyses, and engineering testing to verify the designs and design changes. Document results in engineering reports and laboratory notebooks

• Works closely with strategic partners and vendors to support current products and initiate new production projects and assists in developing processes/techniques to meet contract objectives

• Help ensure designs meet and exceed product specifications, regulatory requirements, and international standards

• Design / develop components to be manufactured via plastic injection molding, stamping, machining, extrusion, and related processes

• Work with manufacturing to ensure feasibility of high-volume assembly in early phase of development cycle

• Translate voice of customer (VOC) feedback into engineering requirements

• Work with suppliers to ensure components meet design requirements & diagnose design / process problems

• Present technical findings or project status to cross functional teams and management through meeting minutes, design reviews, presentations, and other means of communication.

• Travel to supplier and manufacturing sites as required

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident on your resume.

Bachelors of engineering degree and 10+ years of experience in mechanical product and process development

OR

Masters of Engineering degree and 8+ years of experience in mechanical product and process development

Nice to Have

• Experience designing and developing electromechanical assemblies (Drug Delivery Systems or Continuous Glucose Sensors)

• Formal training in Six Sigma methodologies

• Experience with high-volume manufacturing

• Understanding of medical device design controls; lead design reviews and ensure on-time completion of Design Control deliverables

• Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1, MDD & EU MDR.

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here.

This position is eligible for a short-term incentive plan.  Learn more about Medtronic Incentive Plan (MIP) on page 6 here.

The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.