Senior Electrical Manufacturing Engineer

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