Sr Principal Mechanical Engineer Process Development

Job description

We anticipate the application window for this opening will close on - 31 Oct 2025

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all.

You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

**A Day in the Life**
As a member of the Mechanical Engineering R&D group, the individual selected for this role will lead new product development activities of products such as insulin pumps, glucose sensors, and related accessories.

They will work at the intersection of product design and product development, optimizing customer and business needs.

The ideal candidate for this position has the following: extensive experience in new product and process development, design and process characterization, process validation and design verification testing, experience in plastics and electromechanical assemblies in the medical device industry a plus, background in process design, development and qualifications 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 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 access to healthcare.

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.

Job duties to be primarily located on-site in Northridge, CA with the ability to work limited hours remotely.
Responsibilities may include the following and other duties may be assigned.

+ 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 ensure that products are 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
+ 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.

Bachelor of Engineering degree and 10+ years of experience in mechanical product and process development OR Master's degree with a minimum of 8 years relevant experience OR PhD with 6 years relevant experience

**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.

**Physical Job Requirements**

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.



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.

**Benefits & Compensation**

**Medtronic offers a competitive Salary and flexible Benefits Package**
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.

Salary ranges for U.S (excl.

PR) locations (USD):$157,600.00 - $236,400.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California.

The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location.

Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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, and Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees: 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns.

Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan.

Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic)

**About Medtronic**

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people.

From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves.

We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here (http://www.medtronic.com) .

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/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.

In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

If you are applying to perform work for Medtronic, Inc.

(“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here (https://www.medtronic.com/content/dam/medtronic-wide/public/united-states/employee-support-services/careers/la-county-legal-notice.pdf) a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.

We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people.

From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves.

We have the talent, diverse perspectives, and guts to engineer the extraordinary.

**We change lives** .

Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes.

Our industry leadership comes from the passion and ingenuity of our people.

That’s who we are.

Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.

**We build extraordinary solutions as one team** .

With one Medtronic Mindset defining how we work.

Speed and decisiveness run through our DNA.

Diverse perspectives inspire our bold answers to any challenge that comes our way.

And we deliver results the right way, breakthrough after patient breakthrough.

**This life-changing career is yours to engineer** .

By bringing your ambitious ideas, unique perspective and contributions, you will…

+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning

These commitments set our team apart from the rest:

**Experiences that put people first** .

Respect for people is the hallmark of our humanity.

It fuels our team to positively impact even a single life.

And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.

**Life-transforming technologies** .

No matter your role, you contribute to technologies that transform lives.

What we build empowers patients to live life on their terms.

**Better outcomes for our world** .

Here, it’s about more than the bottom line.

Our Mission to improve human welfare drives us.

We advance healthcare, society, and equity with every design, inside and outside our walls.

**Insight-driven care** .

Fresh viewpoints.

Cutting-edge AI, data, and automation.

You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/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.

In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees.

For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) .

For updates on job applications, please go to the candidate login page and sign in to check your application status.

If you need assistance completing your application please email AskHR@medtronic.com

To request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com

Required Skill Profession

Other General