Senior Electrical Manufacturing Engineer

MiniMed•Northridge, CA

About The Position

MiniMed is seeking an experienced Senior Electrical Manufacturing Engineer to lead the development, optimization, validation, and sustaining of complex PCBA manufacturing processes in a highly regulated medical-device environment. The role serves as a technical subject matter expert, leads cross-functional initiatives, and supports high-quality, reliable PCBA solutions for life-critical medical products while meeting applicable quality and regulatory standards. The engineer leads PCBA manufacturing engineering for new product introduction, from early development through production transfer and ramp. They work with R&D and design engineering on manufacturability and assembly decisions, establish process qualification and production-readiness plans, and provide technical leadership and mentorship across the organization. The position also oversees process quality, risk management, suppliers and contract manufacturers, and continuous improvement activities. The work takes place in a fast-paced, collaborative medical-device manufacturing environment and combines office-based engineering with hands-on production-floor activities. It may involve occasional travel to supplier sites, contract manufacturers, or global facilities, up to 15–20%, and work in clean-room and ESD-controlled environments.

Requirements

Bachelor's degree and at least 4 years of relevant experience, or an advanced degree and at least 2 years of relevant experience.
Demonstrated experience leading NPI programs and complex process validation activities.
Expertise in SMT and through-hole assembly processes.
Expertise in IPC standards, including IPC-A-610 and J-STD-001.
Expertise in reflow, wave, and selective soldering.
Expertise in AOI, X-ray, and SPI inspection systems.
Expertise in DFM/DFA principles and application.
Expertise in IQ/OQ/PQ process validation.
Expertise in FDA 21 CFR Part 820 and ISO 13485.
Expertise in FMEA and ISO 14971 risk management.
Expertise in root-cause analysis methods, including 8D, 5-Why, and DOE.
Expertise in statistical process control.
Knowledge of conformal coating and cleaning processes.
Knowledge of Six Sigma/Lean Manufacturing.
Knowledge of ERP/MES systems, such as SAP or Oracle.
Ability to lead cross-functional teams and influence without direct authority.
Strong project-management skills and ability to manage multiple priorities.
Strong analytical and problem-solving capabilities and a data-driven approach.
Excellent written and verbal communication skills, including presenting to senior leadership.
Ability to mentor and develop junior engineering talent.
Ability to collaborate effectively with R&D, Quality, Supply Chain, and Regulatory teams.

Nice To Haves

8–12+ years of progressive experience in PCBA manufacturing engineering.
Five years of experience in a regulated medical-device, aerospace, or defense manufacturing environment.
Master's degree in Electrical Engineering, Manufacturing Engineering, or a related field.
IPC-A-610 Certified Trainer (CIT) or IPC Specialist certification.
Six Sigma Green Belt or Black Belt certification.
PMP certification.
Experience with implantable or active medical devices, such as insulin pumps, neurostimulators, or cardiac devices.
Knowledge of RoHS, REACH, and environmental compliance requirements.
Experience with AOI programming and optimization.
Familiarity with Industry 4.0 or Smart Manufacturing technologies.
Background in ESD control program development and management.
Experience supporting FDA inspections or Notified Body audits.

Responsibilities

Lead design, development, validation, and continuous improvement of PCBA manufacturing processes, including SMT, through-hole assembly, reflow, wave and selective soldering, and advanced cleaning.
Improve process capability using statistical methods and engineering techniques to achieve high yields and quality metrics.
Own full process qualification and validation activities, including IQ/OQ/PQ, from planning through execution and approval.
Develop and implement DFM and DFA guidelines and ensure adoption by design engineering teams.
Lead root-cause analysis of complex, recurring, or high-impact PCBA manufacturing failures.
Evaluate, qualify, and implement new materials, equipment, and technologies.
Define and own process control plans, FMEAs, and control strategies for critical PCBA processes.
Serve as the primary PCBA manufacturing engineering lead for NPI programs from concept through production transfer.
Lead manufacturing readiness reviews and ensure PCBA processes are production-ready before launch.
Collaborate with R&D and design engineering during early development on 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.
Act as the technical subject matter expert for PCBA process topics across the organization.
Mentor and coach junior and mid-level engineers, technicians, and operators.
Lead technical reviews, design reviews, and process audits with internal and external stakeholders.
Develop and deliver training on PCBA processes, IPC standards, and quality requirements.
Represent manufacturing engineering in cross-functional core teams and program reviews.
Ensure PCBA processes comply with IPC standards and applicable medical-device regulatory requirements.
Lead CAPA investigations and systemic corrective actions for PCBA-related non-conformances and customer complaints.
Own process-level risk management in accordance with ISO 14971.
Support regulatory submissions, internal audits, and external FDA and Notified Body inspections related to PCBA manufacturing.
Drive implementation of SPC and key process indicators to monitor and control PCBA process performance.
Lead qualification and ongoing oversight of contract manufacturers and PCBA suppliers.
Conduct supplier audits and technical reviews to assess process capability and quality performance.
Define supplier quality requirements and work with supply chain to resolve supplier-related PCBA issues.
Evaluate and approve material and component changes from a manufacturing process perspective.
Champion Lean Manufacturing and Six Sigma methods to reduce waste and improve 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.
Track and report yield, defect rates, cycle time, and other PCBA process metrics.

Benefits

Competitive salary and flexible benefits package.
Health, dental, and vision insurance.
Health Savings Account and Healthcare Flexible Spending Account.
Life insurance.
Long-term disability leave and short-term disability coverage.
Dependent daycare spending account.
Incentive plans.
401(k) plan with company match.
Paid time off and holidays.
Employee Stock Purchase Plan.
Employee Assistance Program.
Eligible employees may have access to a Non-qualified Retirement Plan Supplement and Capital Accumulation Plan, subject to IRS minimum earnings requirements.