Sr Process Engineer

Senior Process Engineer

The Process Engineer will play a key role in the Advanced Manufacturing Engineering Joining/Welding group, developing, optimizing, and scaling joining and welding processes that enable safe, reliable, and cost-effective manufacturing of complex medical devices and other highly regulated products. This role focuses on laser and resistance welding applications, partnering closely with design engineering, operations, quality, and suppliers to launch new products and continuously improve existing manufacturing lines. The position combines hands-on process development, validation, and troubleshooting with strategic contributions to technology innovation, process capability, and continuous improvement in a regulated environment.

Responsibilities

• Design, develop, and qualify robust joining and welding processes, including laser welding, resistance welding, and micro-welding, for new and existing products.
• Lead process development and improvement initiatives using structured problem-solving and DMAIC principles to improve yield, throughput, and process capability.
• Own critical welding process documentation, including control plans, work instructions, process instructions, validation protocols and reports, and engineering change orders.
• Collaborate with cross-functional team members and operations representatives to understand and execute project scope, ensuring alignment of process development with product and business objectives.
• Transfer welding and joining processes from development to production, ensuring smooth ramp-up, operator training, and long-term sustainability of manufacturing lines.
• Plan and execute validation work for process qualification, including running processes, collecting and analyzing data, and preparing clear and compliant validation reports.
• Characterize and optimize welding parameters through design of experiments (DOE), capability studies, and data analysis, leveraging statistical tools to support evidence-based decision-making.
• Collaborate with equipment vendors on specification, selection, installation, and qualification of welding and joining equipment, tooling, fixtures, and automated cells.
• Recommend and implement equipment and process modifications to meet quality standards, improve production efficiencies, and increase production yields for existing products.
• Integrate equipment and material capabilities to meet process module target specifications and technology target specifications.
• Review product development requirements for compatibility with processing methods to help determine manufacturing costs, schedules, and process feasibility.
• Interact with product design and development teams to ensure that designs and processes are compatible and manufacturable.
• Develop and conduct statistical analyses of process performance and recommend updates to documentation and procedures based on data-driven insights.
• Lead the innovation, development, and optimization of new manufacturing concepts, processes, and procedures, including scouting and feasibility work, material selection, and process and equipment selection.
• Oversee tooling, fixture, and equipment installation and assess process inputs and outputs to ensure alignment with requirements and specifications.
• Develop manufacturing processes that are suitable for statistical process control and establish appropriate measurement systems and control methods.
• Support nonconformance investigations and CAPA activities related to welding and joining processes, driving root cause analysis and implementing durable corrective and preventive actions.
• Ensure that processes and procedures comply with applicable quality and regulatory requirements, including ISO standards and FDA expectations.
• Provide technical and sustaining engineering support in manufacturing areas, addressing day-to-day process issues and supporting production needs.
• Formulate, deliver, and manage assigned projects, working with stakeholders to achieve defined objectives, timelines, and quality targets.
• Communicate effectively with internal and external stakeholders, including vendors, to exchange information, resolve issues, and influence decision-making.
• Provide guidance, coaching, and informal mentoring to lower-level professionals, and when required, direct project work and review the work products of others.
• Contribute to a culture of continuous improvement, safety, and operational excellence within the joining and welding team and the broader manufacturing organization.

Essential Skills

• Bachelor's degree in Engineering (such as Mechanical, Welding, Materials, Biomedical) or a related field (such as Materials Science or Physics).
• Minimum of 5 years of relevant engineering experience in manufacturing process engineering or advanced manufacturing engineering, or at least 3 years of relevant experience 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 methodologies such as DMAIC, root cause analysis, 5 Whys, and fishbone diagrams.
• Ability to interpret engineering drawings and specifications and translate them into practical manufacturing processes and documentation.
• Experience working effectively with cross-functional teams in a regulated environment.
• Strong process development, including DOE, problem solving, process improvement, and validation activities.
• Technical in engineering or science, with laser welding experience preferred (IPG laser systems experience is particularly valuable).
• Advanced knowledge of the job area, combining breadth and depth of technical expertise typically obtained through education and experience.
• Ability to work independently under limited supervision, determining and developing approaches to complex technical solutions.
• Strong analytical and statistical skills to perform in-depth data analysis and provide recommendations on process improvements.
• Effective communication skills to interact with internal stakeholders and external vendors and to document technical work clearly and comprehensively.

Additional Skills & Qualifications

• Experience in medical device, pharmaceutical, automotive, aerospace, nuclear, or other highly regulated industries.
• Prior experience with laser systems, welding equipment, or automated joining cells, including equipment selection, installation, and qualification.
• Familiarity with automation, robotics, vision systems, or custom equipment used in joining and welding applications.
• Knowledge of design for manufacturability (DFM), design of experiments (DOE), and statistical analysis tools such as Minitab or similar software.
• Familiarity with quality systems and regulations, including ISO standards, FDA Quality System Regulations (QSR), and Good Manufacturing Practices (GMP).
• Experience supporting new product introductions and transferring processes from development to full-scale production.
• Exposure to Lean, Six Sigma, or formal continuous improvement programs; Green Belt certification or higher is preferred.
• Practical knowledge of project management principles, including planning, execution, and stakeholder communication.
• Ability to build relationships and consensus across functions to achieve project and work group objectives.
• Experience mentoring or coaching other engineers or technical staff, and comfort leading projects that require delegation and review of others' work.

Work Environment

This role operates within an advanced manufacturing and engineering environment focused on joining and welding technologies for complex, high-reliability products. The Process Engineer works primarily on-site in a development and production setting that includes laser welding systems, resistance welding equipment, micro-joining tools, and associated fixtures, tooling, and automated cells. The environment involves frequent interaction with cross-functional partners in research and development, operations, quality, and supply chain, as well as collaboration with external equipment vendors. Work includes time in laboratories and on the manufacturing floor, performing process development, running validation builds, collecting data, and supporting production teams. The team culture emphasizes safety, continuous improvement, innovation, and strict adherence to quality systems and regulatory requirements such as ISO standards, FDA QSR, and GMP. Standard business hours typically apply, with flexibility as needed to support production schedules, equipment qualifications, and project milestones. Attire generally aligns with a professional office setting combined with appropriate manufacturing or laboratory requirements, which may include personal protective equipment when working on the production floor or with welding and joining equipment.

Job Type & Location

This is a Contract position based out of Brooklyn Park, MN.

Pay and Benefits

The pay range for this position is $40.00 - $65.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Brooklyn Park, MN.

Application Deadline

This position is anticipated to close on Aug 26, 2