***W2 ONLY, C2C candidates, or Candidates with the following Visa Status will not be accepted: H1B, OPT, OPT-STEM
Sr. Process Engineer (12 month contract //Onsite daily Brooklyn Center, MN)
:Top 3 Required Skills
- :Process Development: DOE, problem solving, process improvement and validatio
- nMedical device experience or other regulated industry (aerospace, nuclear, etc.
- )Minimum technical background (engineering/science degree or experience), laser welding experience preferred, IPG ideall
y
Primary Responsibilitie
- s:Collaborate with cross functional support members and operations representatives to understand and execute on project scope and timeli
- neLead and own critical welding process documentation, including control plans, process instructions, validation protocols/reports, and engineering change orde
- rsExecute validation work for process qualification, including running processes, data analysis, and report documentati
on
Target Years of Experience: 5+ years of process development and implementation and hands on experience with welding or micro/thermal join
ing
Descript
ion:As a Sr Process Engineer in our client’s Advanced Manufacturing Engineering (AME) Joining/Welding group, 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 our client’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 applicati
ons.
Du
- ties: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 laun
- ches.Lead process improvement and cost reduction projects using structured problem solving and DMAIC principles to improve yield, throughput, and process capabi
- lity.Own critical welding process documentation, including control plans, process instructions, validation protocols/reports, and engineering change or
- ders.Partner with manufacturing representatives to transfer processes from development to production, ensuring smooth ramp up, training, and long-term sustainabi
- lity.Characterize and optimize welding parameters through DOEs, capability studies, and data analysis, leveraging statistical tools to drive evidence-based decis
- ions.Collaborate with equipment vendors on specification, selection, installation, and qualification of welding and joining equipment and fixt
- ures.Support nonconformance investigations and CAPA activities related to welding/joining processes, driving root cause analysis and durable corrective act
- ions.Contribute to a culture of continuous improvement, safety, and compliance with quality and regulatory requirements (including ISO 13485 and FDA expectati
ons).
Must
- Haves: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 d
- egree.Hands on experience with at least one of the following: battery or capacitor manufacturing, laser welding, resistance welding, micro joining, or similar thermal joining proc
- esses.Demonstrated experience applying structured problem solving (e.g., DMAIC, root cause analysis, 5 Whys, fish
- bone).Ability to interpret engineering drawings and specifications, and to work effectively with cross functional teams in a regulated enviro
nment.
Nice to
- Haves:Experience in medical device, pharmaceutical, automotive, or other highly regulated indu
- stries.Prior work with laser systems, welding equipment, or automated joining cells, including equipment selection and qualifi
- cation.Familiarity with automation, robotics, vision systems, or custom equipment for joining/w
- elding.Knowledge of design for manufacturability (DFM), design of experiments (DOE), and statistical analysis tools (Minitab or si
- milar).Familiarity with quality systems and regulations (ISO 13485, FDA QSR
- , GMP).Experience supporting new product introductions and transferring processes from development to prod
- uction.Exposure to Lean, Six Sigma, or formal continuous improvement programs (Green Belt or higher pref
erred).
Additional
- Duties:Provides technical and sustaining engineering support in a manufacturi
- ng 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 p
- roducts.Integrates equipment and material capabilities to meet process module target specifications and technology target specifi
- cations.Reviews product development requirements for compatibility with processing methods to determine costs and sc
- hedules.Interacts with product design and development personnel to ensure that processes and designs are com
- patible.May develop and conduct statistical analysis or recommend additions to docume
- nt work.Leads the innovation, development and/or optimization of new manufacturing concepts, processes, and procedures for transfer to manufacturing ope
- rations.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 requi
- rements.Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement
- systems.Ensures processes and procedures follow regu