Process development engineer Jobs in Minneapolis, MN

JOB DESCRIPTION

Can you please confirm your top 3 skills sets required?
Process Development: DOE, problem solving, process improvement and validation
Medical device experience or other regulated industry (aerospace, nuclear, etc.)
Minimum technical background (engineering/science degree or experience), laser welding experience preferred, IPG ideally
Can you please confirm the 3 main responsibilities/day to day activities required for this role?
Collaborate with cross functional support members and operations representatives to understand and execute on project scope and timeline
Lead and own critical welding process documentation, including control plans, process instructions, validation protocols/reports, and engineering change orders
Execute validation work for process qualification, including running processes, data analysis, and report documentation
What products (if any) will this role support?
CRM pacing and defibrillation devices
What is your target years of experience?
5+ years
When do you plan to start interviewing?
September
Will you be looking to hire and start ASAP or will the start date be delayed?
ASAP
Will the contingent worker be working remotely or onsite, or both (if both, please confirm possible schedule)?
Onsite

As a Sr Process Engineer in the Advanced Manufacturing Engineering (AME) Joining/Welding group at MECC, you will play a key role in developing, optimizing, and scaling the joining and welding processes that enable safe, reliable, and cost-effective medical device manufacturing for ***'s portfolio of cardiovascular and neurological products. You will collaborate closely with design engineering, operations, quality, and supplier partners to launch new products and continuously improve existing lines, with a focus on laser and resistance welding applications.
A Day in the Life
Design, develop, and qualify robust joining and welding processes (e.G., laser, resistance, micro welding) for new and existing products, in alignment with AME s mission to lead process development for project launches.
Lead process improvement and cost reduction projects using structured problem solving and DMAIC principles to improve yield, throughput, and process capability.
Own critical welding process documentation, including control plans, process instructions, validation protocols/reports, and engineering change orders.
Partner with manufacturing representatives to transfer processes from development to production, ensuring smooth ramp up, training, and long term sustainability.
Characterize and optimize welding parameters through DOEs, capability studies, and data analysis, leveraging statistical tools to drive evidence based decisions.
Collaborate with equipment vendors on specification, selection, installation, and qualification of welding and joining equipment and fixtures.
Support nonconformance investigations and CAPA activities related to welding/joining processes, driving root cause analysis and durable corrective actions.
Contribute to a culture of continuous improvement, safety, and compliance with quality and regulatory requirements (including ISO 13485 and FDA expectations).
Must Have: Minimum Requirements
Bachelor s degree in Engineering (Mechanical, Welding, Materials, Biomedical, etc) or related field (Materials Science, Physics, etc).
5+ years of relevant engineering experience in manufacturing, process, or advanced manufacturing engineering;or 3+ years with an advanced degree.
Hands on experience with at least one of the following: battery or capacitor manufacturing, laser welding, resistance welding, micro joining, or similar thermal joining processes.
Demonstrated experience applying structured problem solving (e.G., DMAIC, root cause analysis, 5 Whys, fishbone).
Ability to interpret engineering drawings and specifications, and to work effectively with cross functional teams in a regulated environment.
Nice to Have
Experience in medical device, pharmaceutical, automotive, or other highly regulated industries.
Prior work with laser systems, welding equipment, or automated joining cells, including equipment selection and qualification.
Familiarity with automation, robotics, vision systems, or custom equipment for joining/welding.
Knowledge of design for manufacturability (DFM), design of experiments (DOE), and statistical analysis tools (Minitab or similar).
Familiarity with quality systems and regulations (ISO 13485, FDA QSR, GMP).
Experience supporting new product introductions and transferring processes from development to production.
Exposure to Lean, Six Sigma, or formal continuous improvement programs (Green Belt or higher preferred).
About the AME Joining/Welding Group at MECC
The AME Joining/Welding team partners across R&D and Operations to develop advanced joining processes and introduce new technologies that enable complex implantable and external therapies. Located at MECC (Brooklyn Center/MECC, MN), the team supports multiple businesses and platforms by delivering scalable, high capability welding solutions for new product introductions and continuous improvement of existing lines.
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Responsibilities may include the following and other duties may be assigned. Provides technical and sustaining engineering support in a manufacturing area. Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products. Integrates equipment and material capabilities to meet process module target specifications and technology target specifications. Reviews product development requirements for compatibility with processing methods to determine costs and schedules. Interacts with product design and development personnel to ensure that processes and designs are compatible. May develop and conduct statistical analysis or recommend additions to document work. Leads the innovation, development and/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations. This can include scouting and feasibility work, material selection, process and equipment selection, tooling / fixture and equipment installation and assessment of inputs, outputs and alignment to requirements. Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems. Ensures processes and procedures are in compliance with regulations. TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies from design to implementation - while adhering to policies, using specialized knowledge and skills. DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists;may manage projects and processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product. Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.