Job description

We anticipate the application window for this opening will close on - 3 Nov 2026 At MiniMed, you can begin a lifelong career of exploration and innovation, while helping make a difference in the lives of people living with diabetes around the globe. You ll lead with purpose, breaking down barriers to innovation for a more connected, compassionate world. About the Role We are seeking an experienced and highly skilled Senior Electrical Manufacturing Engineer to lead and drive the development, optimization, and sustaining of complex PCBA manufacturing processes within a highly regulated medical device environment. This senior-level role requires deep technical expertise, strong leadership capabilities, and a proven track record of delivering high-quality PCBA solutions for life-critical medical products. The ideal candidate will serve as a technical subject matter expert (SME), driving continuous improvement initiatives, leading cross-functional teams, and ensuring that all PCBA processes meet the most stringent quality, reliability, and regulatory standards in the medical device industry. Responsibilities may include the following and other duties may be assigned. Advanced Process Engineering & Development Lead the design, development, validation, and continuous improvement of complex PCBA manufacturing processes including SMT, through-hole, reflow soldering, wave soldering, selective soldering, and advanced cleaning processes Drive process capability improvements using statistical methods and advanced engineering techniques to achieve best-in-class yields and quality metrics Own and lead full process qualification and validation (IQ/OQ/PQ) activities from planning through execution and approval Develop and implement Design for Manufacturability (DFM) and Design for Assembly (DFA) guidelines and ensure adoption by design engineering teams Lead advanced root cause analysis for complex, recurring, or high-impact PCBA manufacturing failures Evaluate, qualify, and implement new materials, equipment, and technologies to improve process performance and competitiveness Define and own process control plans, FMEAs, and control strategies for critical PCBA processes New Product Introduction (NPI) Leadership Serve as the primary PCBA manufacturing engineering lead for NPI programs, from concept through full production transfer Lead manufacturing readiness reviews and ensure all PCBA processes are production-ready prior to launch Collaborate with R&D and design engineering teams during early-stage development to influence PCB layout, component selection, and assembly design decisions Define pilot build strategies, process qualification plans , and production ramp activities Develop and present manufacturing risk assessments and mitigation strategies to program leadership Technical Leadership & Mentorship Serve as the technical SME for all PCBA process-related topics across the organization Mentor and coach junior and mid-level manufacturing engineers, technicians, and operators Lead technical reviews, design reviews, and process audits with internal and external stakeholders Develop and deliver training programs on PCBA processes, IPC standards, and quality requirements Represent manufacturing engineering in cross-functional core teams and program reviews Quality, Compliance & Risk Management Ensure all PCBA processes comply with IPC standards (IPC-A-610, IPC-7711/7721, IPC-J-STD-001) and medical device regulatory requirements Lead CAPA investigations and drive systemic corrective actions for PCBA-related non-conformances and customer complaints Own process-level risk management activities in accordance with ISO 14971 Ensure compliance with FDA 21 CFR Part 820, ISO 13485, IEC 60601 , and other applicable standards Support regulatory submissions, internal audits, and external inspections (FDA, Notified Body) related to PCBA manufacturing Drive implementation of Statistical Process Control (SPC) and key process indicators (KPIs) to monitor and control PCBA process performance Supplier & Contract Manufacturer Management Lead qualification and ongoing oversight of contract manufacturers (CMs) and PCBA suppliers Conduct supplier audits and technical reviews to assess process capability and quality performance Define supplier quality requirements and collaborate with supply chain to resolve supplier-related PCBA issues Evaluate and approve material and component changes from a manufacturing process perspective Continuous Improvement & Innovation Champion Lean Manufacturing and Six Sigma methodologies to drive waste reduction and process efficiency Lead or participate in kaizen events, value stream mapping , and other continuous improvement initiatives Identify and implement automation and digitalization opportunities in PCBA manufacturing processes Track and report on yield, defect rates, cycle time , and other key PCBA process metrics Required Qualifications: Requires a bachelor s degree and minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years of relevant experience. Preferred Qualifications: 8–12 years of progressive experience in PCBA manufacturing engineering 5 years of experience in a regulated medical device, aerospace, or defense manufacturing environment Demonstrated experience leading NPI programs and complex process validation activities Technical Skills - SMT & Through-Hole Assembly Processes Expert - IPC Standards (IPC-A-610, J-STD-001) Expert - Reflow, Wave & Selective Soldering Expert - AOI, X-Ray & SPI Inspection Systems Expert - DFM / DFA Principles & Application Expert - IQ/OQ/PQ Process Validation Expert - FDA 21 CFR Part 820 / ISO 13485 Expert - FMEA & Risk Management (ISO 14971) Expert - Root Cause Analysis (8D, 5-Why, DOE) Expert - Statistical Process Control (SPC) Expert - Conformal Coating & Cleaning Processes Six Sigma / Lean Manufacturing ERP / MES Systems (SAP, Oracle) Contract Manufacturer Management Proven ability to lead cross-functional teams and influence without direct authority Strong project management skills with the ability to manage multiple priorities simultaneously Excellent analytical and problem-solving capabilities with a data-driven approach Outstanding written and verbal communication skills , including the ability to present to senior leadership Demonstrated ability to mentor and develop junior engineering talent Strong collaboration skills with the ability to work effectively across R&D, Quality, Supply Chain, and Regulatory teams Master s degree in Electrical Engineering, Manufacturing Engineering, or related field IPC-A-610 Certified Trainer (CIT) or IPC Specialist certification Six Sigma Green Belt or Black Belt certification PMP (Project Management Professional) certification Experience with implantable or active medical devices (e.g., insulin pumps, neurostimulators, cardiac devices) Knowledge of RoHS, REACH, and environmental compliance requirements Experience with automated optical inspection (AOI) programming and optimization Familiarity with Industry 4.0 / Smart Manufacturing technologies Background in ESD control program development and management Experience supporting FDA inspections or Notified Body audits Work Environment Fast-paced, highly collaborative medical device manufacturing environment Combination of office-based engineering work and hands-on production floor activities May require occasional travel to supplier sites, contract manufacturers, or global facilities (up to 15–20%) Clean room and ESD-controlled manufacturing environments Opportunity to work on cutting-edge medical technologies that directly improve patient outcomes 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 MiniMed offers a competitive salary and flexible benefits package At MiniMed, we put people first. A commitment to our employees lives at the core of our values: We recognize their contributions. They share in the success they help create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life. Salary ranges for U.S (excl. PR) locations (USD):$87,000.00 - $149,000.00 For roles located in California, Seattle WA, Washington DC, Boston MA, and New York City, the salary range is $97,000.00 - $165,000.00 USD. Actual compensation may vary based on factors including experience, education, certifications, skills, market conditions, internal equity, and geographic location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). At MiniMed, we are committed to supporting the well-being and financial security of our employees. Regular employees working 20 or more hours per week are eligible for a robust benefits package, including health, dental, and vision insurance, as well as access to a Health Savings Account, Healthcare Flexible Spending Account, life insurance, long-term disability leave, and a dependent daycare spending account. In addition, all regular employees enjoy incentive plans, a 401(k) plan with company match, short-term disability coverage, paid time off and holidays, participation in our Employee Stock Purchase Plan, and access to our Employee Assistance Program. Eligible employees may also benefit from our Non-qualified Retirement Plan Supplement and Capital Accumulation Plan, subject to IRS minimum earnings requirements. Please note that “regular employees” refers to those who are not temporary staff, such as interns, and some benefits may not apply to employees in Puerto Rico. For further details about our comprehensive benefits, we encourage you to visit the link below. MiniMed Benefits Overview About MiniMed MiniMed is a full-stack insulin delivery company dedicated to supporting people living with diabetes through every step of their journey — when and how they need it. For more than 40 years, we’ve been committed to redefining what’s possible: intelligent dosing systems designed for real life, predictive insights that stay a step ahead, and always on support when it’s needed most. At the heart of everything we do is a simple Mission: to make every day a better day for people with diabetes. Learn more about our business, and our mission here . It is the policy of MiniMed 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, familial status, membership or activity in a local human rights commission, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state, or local law. In addition, MiniMed will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to perform work for MiniMed 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 MiniMed reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. MiniMed 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.

Requirements

Must-haves

We anticipate the application window for this opening will close on - 3 Nov 2026
Advanced Process Engineering & Development
Drive process capability improvements using statistical methods and advanced engineering techniques to achieve best-in-class yields and quality metrics
Own and lead full process qualification and validation (IQ/OQ/PQ) activities from planning through execution and approval
Develop and implement Design for Manufacturability (DFM) and Design for Assembly (DFA) guidelines and ensure adoption by design engineering teams
Lead advanced root cause analysis for complex, recurring, or high-impact PCBA manufacturing failures
Evaluate, qualify, and implement new materials, equipment, and technologies to improve process performance and competitiveness
Define and own process control plans, FMEAs, and control strategies for critical PCBA processes
New Product Introduction (NPI) Leadership
Serve as the primary PCBA manufacturing engineering lead for NPI programs, from concept through full production transfer
Lead manufacturing readiness reviews and ensure all PCBA processes are production-ready prior to launch
Collaborate with R&D and design engineering teams during early-stage development to influence PCB layout, component selection, and assembly design decisions

Nice-to-haves

Demonstrated experience leading NPI programs and complex process validation activities
Technical Skills - SMT & Through-Hole Assembly Processes
Expert - IPC Standards (IPC-A-610, J-STD-001)
Expert - Reflow, Wave & Selective Soldering
Expert - AOI, X-Ray & SPI Inspection Systems
Expert - DFM / DFA Principles & Application
Expert - IQ/OQ/PQ Process Validation
Expert - FDA 21 CFR Part 820 / ISO 13485
Expert - FMEA & Risk Management (ISO 14971)
Expert - Root Cause Analysis (8D, 5-Why, DOE)
Expert - Statistical Process Control (SPC)
Expert - Conformal Coating & Cleaning Processes

Application prep

Use the role’s language and application details while tailoring your materials.

Platform: workday
Effort: long

Benefits

Benefits detected in the listing.

Dental

Vision

401(K)

Paid Time Off