Über diese Principal Manufacturing Engineer - Injection Molding Stelle bei Medtronic
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.
A Day in the Life
This specialized Principal Manufacturing & Injection Molding Engineer role bridges advanced plastics processing with regulated medical device manufacturing. This position owns the entire lifecycle of finished devices which includes bioabsorbable components — from initial tooling design and scientific process development to component assemblies, equipment qualification, and final packaging. A critical differentiator for this role is deep technical expertise in handling highly sensitive absorbable/bioresorbable polymers (such as PLA, PGA, and PLGA) within an ISO 13485 / FDA-regulated cleanroom manufacturing environment.At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 5 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.
Responsibilities may include the following and other duties may be assigned.
- Establish, optimize, and document robust, repeatable injection molding processes utilizing Scientific Molding principles and Design of Experiments (DOE).
- Manage strict process controls tailored to bioabsorbable resins. Optimize parameters to minimize Inherent Viscosity (IV) loss, strictly control material residence time, and prevent thermal degradation.
- Lead Design for Manufacturability (DFM) reviews for complex, multi-cavity, and micro-molding tools. Partner with toolmakers to oversee mold construction, modifications, and steel resizing.
- Team with manufacturing and quality personnel on a daily basis to review / disposition production defects and provides potential process and/or equipment corrective actions to assure production schedules and quality expectations are met.
- Review product field returns to determine root cause of potential manufacturing defects then develop and implement effective corrective actions.
- Create and execute engineering studies, DOE, Bill of material updates, and validation documentation for accuracy, statistical validity, and compliance.
- Served as lead engineer for molding and automated assembly equipment design specifications, request for quotes, vendor selection activities, equipment design review, FAT, SAT, and validation activities.
- Lead Capacity Expansion and Process Improvement Projects to increase yields, reduce scrap, and Improve Product Quality
- Author standard operating procedures (SOPs), design custom manufacturing fixtures, and train operators and technicians on new production lines.
- Author and execute comprehensive validation protocols (IQ/OQ/PQ) for molding machines, automated and manual assemblies, and multi-cavity molds in compliance with FDA 21 CFR Part 820.
- Lead risk assessment activities, including the creation and maintenance of PFMEAs.
- Conduct root-cause investigations for production anomalies, owning the execution of Non-Conformance Reports (NCR) and Corrective and Preventive Actions (CAPA).
Required Qualifications
- Bachelor's degree with a minimum of 7 years of relevant experience
- OR Master's degree with a minimum of 5 years relevant experience
- OR PhD with a minimum of 3 years relevant experience.
Preferred Qualifications
- Minimum of 5 - 7 years of injection molding experience, preferably in a regulated manufacturing environment, highly preferred.
- Bachelor’s or advanced degree in Plastics Engineering, Polymer Engineering, Manufacturing Engineering, or Mechanical Engineering.
- Proven track record working with bioabsorbable or resorbable polymers (PLA, PLGA, PGA) is highly preferred.
- Demonstrated knowledge of GD&T and PFMEA.
- Significant Plastics manufacturing process experience, Mold Operation, Mold design, Mold Maintenance, Mold Flow analysis,
- Experience in automated machine design, repair, and troubleshooting.
- Solid presentation and computer skills (Excel /Word / PowerPoint/ Projects/ AutoCAD/ SolidWorks, etc.)
- Strong background in Statistical Process Control (SPC), Minitab, and data analysis to evaluate process capability (Cpk).
- Project management skills to keep projects on track
- Self-motivated attitude with the ability to multitask and thrive in a fast-paced environment
- Excellent Interpersonal communication skills
- Solid working knowledge of ISO 13485, ISO 14644 (cleanroom standards), and FDA medical device manufacturing regulations.
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
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.
U.S. Work Authorization & Sponsorship
At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Recruitment Fraud Alert
We are aware of phishing scams targeting job seekers. Please keep the following in mind:
Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.
Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.
If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.
If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [email protected].
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.
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
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 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.
