Getinge · 5 hours ago
Sr Manufacturing Engineer
Boston, MA
Full-time
Onsite
Senior Level
$115K/yr - $135K/yr
5+ years expGetinge is a company dedicated to making life-saving technology accessible for more people. As a Senior Manufacturing Engineer, you will lead process improvement initiatives, optimize manufacturing operations, and ensure product quality and efficiency while collaborating with cross-functional teams.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Analyze current manufacturing processes to identify inefficiencies, bottlenecks, and opportunities for improvement
Develop and implement strategies to reduce cycle time, scrap, and overall production costs while maintaining quality standards
Drive Lean Manufacturing initiatives, including Kaizen events and Value Stream Mapping
Develop, review and approve validation protocols and (IQ/OQ/PQ) and reports for manufacturing processes, equipment, and software systems in compliance with ISO 13485 and FDA requirements
Ensure all validation activities and documentation comply with ISO 13485, FDA 21 CFR Part 11/820, and applicable GMP requirements
Lead and review any changes to process documentation, SOPs, and work instructions
Work closely with contract manufacturers to implement engineering changes, monitor process capability (Cp/Cpk), and ensure compliance with ISO 13485 and supplier quality agreements
Provide technical support and guidance to ensure alignment with company standards and product specifications; oversee any process-related investigations
Support design for manufacturability (DFM) and design for assembly (DFA) during product development phases
Develop and validate manufacturing processes for new products, including tooling and equipment requirements
Support coordination of pilot runs and ensure smooth transition to full-scale production
Collect and analyze production data to monitor process performance and identify trends
Prepare reports and present findings to management with actionable recommendations
Conduct root cause analysis and implement corrective and preventive actions (CAPA) for production defects
Qualification
Required
Bachelor's degree in Mechanical, Industrial, or Manufacturing Engineering
5+ years of experience in manufacturing engineering, preferably in a high-volume or complex production environment
Demonstrated track record of success in process development and Lean Manufacturing/Six Sigma methodologies
Advanced knowledge of manufacturing processes such as injection molding, CNC machining, and complex assembly
Proficiency in CAD/CAM tools (e.g., SolidWorks) and familiarity with GD&T principles
Strong background in Lean Manufacturing, Kaizen, and Six Sigma methodologies
Proficiency statistics tools (e.g., Minitab, JMP)
Ability to conduct time studies, capacity analysis, and implement takt time improvements
Strong project management skills, with the ability to manage multiple projects simultaneously and drive initiatives to completion on time and within budget
Ability to analyze complex data sets to identify possible trends and root causes; expertise in failure mode and effects analysis (FMEA)
Knowledge of medical device regulatory submissions (e.g., supporting DHF, DMR updates); familiar with ISO 9001 and ISO 13485 standards and requirements
Excellent communication and interpersonal skills for collaboration with cross-functional teams
Ability to work under time constraints and adapt to changing priorities in a fast-paced environment
Willingness to travel occasionally, as needed, to visit manufacturing partners, vendors, and processing facilities to support investigations or process changes
Preferred
Six Sigma Green Belt or Black Belt
Certified Manufacturing Engineer (CMfgE)
Background in medical devices
Experience with cleanroom manufacturing and/or knowledge of sterilization processes
Benefits
Health, Dental, and Vision insurance benefits
401k plan with company match
Paid Time Off
Wellness initiative & Health Assistance Resources
Life Insurance
Short and Long Term Disability Benefits
Health and Dependent Care Flexible Spending Accounts
Commuter Benefits
Parental and Caregiver Leave
Tuition Reimbursement
Company
Getinge
Getinge identifies customer issues and promotes clinical and economic benefits and follow and support the customer decision process.
10001+ employees
H1B Sponsorship
Getinge has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (3)
2023 (2)
2022 (2)
2021 (2)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
$539.31M2017-10-19Post Ipo Equity· $539.31M
2002-06-28IPO
Leadership Team
C
Christoffer Å.
Chief Information Security Officer
Joanna Engelke
EVP Quality Compliance, Regulatory, Medical
Recent News
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