Senior Process Engineer

Boston Scientific

Maple Grove, MNFull-time$124–162K/yrSeen 1w agoSeen in employer's feed 5 days ago

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At a glance

Compensation

$124–162K/yr

Location

Maple Grove, MN

Schedule

Full-time

Work Authorization

Not specified

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Job overview

Boston Scientific seeks a Senior Process Engineer in Maple Grove, Minnesota. The role assesses process capabilities, prioritizes and implements process improvements, and executes project and quality-system deliverables. It also develops production lines and validation documentation, contributes to new product projects, and develops and tests surgical laser and fiber-optic devices. The employer requires a relevant bachelor’s degree or equivalent and five years of experience.

Skills & qualifications

RequiredNice to have

Skills

Process DevelopmentProcess ValidationProcess VerificationDesign of ExperimentsProcess CharacterizationRoot Cause AnalysisProblem SolvingRisk ManagementMolding Process DevelopmentISO 13485 ComplianceFDA 21 CFR Part 820 Compliance

Qualifications

Bachelor's in Mechanical, Industrial, Engineering Technology, or Related Field or Equivalent60 Months Related Experience

Benefits

Medical Insurance

Dental Insurance

401(k) Match

Full job description

Job Duties

Boston Scientific Corporation seeks a Senior Process Engineer at its Maple Grove, MN location.

DUTIES: Assess process capabilities, prioritize process improvement opportunities, and innovate and implement process improvements on platform or derivative projects. Execute the functional deliverables associated with the PDP/TDP, Project Management, and Quality Systems. Plan, organize, and conduct all aspects of technical reviews. Ensure proper documentation is completed to meet quality systems requirements (e.g., BOMs, Routers, FMEAs). Write and review validation protocols and reports applicable to new processes. Develop qualified production lines. Provide Design for Manufacturability (DFM) input to the engineering print package. Contribute ideas to or generate Intellectual Property submissions. Train and/or provide work direction to technicians and engineers and may train manufacturing personnel when required as part of a validation. Serve as a core team member or extended team member on new product projects. Develop lasers, laser systems, fiber optic energy delivery devices, and fiber optic probes. Assemble, align, test, and troubleshoot surgical lasers, laser delivery systems, and single-use devices. Apply broad knowledge of assembly, alignment, powering, and test methodologies and related equipment, as well as in-depth knowledge of Acquisition and Integration space around Production and Process Controls. May require travel/Telecommute.

WORKSITE: 1 Boston Scientific Way, Maple Grove, MN 55369

Minimum Education Required

REQUIREMENTS: Employer requires a Bachelor’s degree or equivalent in Mechanical Engineering, Industrial Engineering, Engineering Technology, or a related field.

Minimum Experience Required

REQUIREMENTS: Employer requires a Bachelor’s degree or equivalent in Mechanical Engineering, Industrial Engineering, Engineering Technology, or a related field plus 60 months experience in the job offered, Engineer, or related occupation. Experience must include: 1) process development, 2) Process Validation & Verification (IQ, OQ, PQ, TMV), 3) Design of Experiments (DOE), 4) Process Characterization, 5) Root Cause Analysis & Problem Solving, 6) Risk Management (PFMEA, DFMEA), 7) Molding Process Development, and 8) ISO 13485 & FDA 21 CFR Part 820 Compliance.