Arthrex · 21 hours ago
Principal Manufacturing Process Engineer
Pendleton, SC
Full-time
Onsite
Lead/Staff
12+ years expArthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. They are seeking a Principal Manufacturing Process Engineer to support new product development and lead process improvement initiatives. The role involves developing validation strategies, managing tooling, and ensuring compliance with industry standards.
Health CareMedical Device
Hiring Manager
Denisse Diaz
Responsibilities
Support new product development/design transfer by leading process development and validation
Develop and support a continuous improvement culture to enhance quality, operational excellence, and cost
Develop and maintain Master Validation Strategies and Master Validation Plans for component manufacturing, device assembly, packaging, data collection, and process efficiency
Draft and execute validation protocols and reports (IQ,OQ/PQ) for manual assembly and mechanized processes
Lead the design, development, and commercialization of new equipment including gathering user requirements, designing equipment mechanical and electrical systems, developing equipment specifications, coordinating quotes and procurement of new equipment with vendors, validation, work instruction development, BOM and Router management, and training of operations
Confers with vendors to determine product specifications and arrange for purchase of equipment, materials, or parts, and evaluates products according to specifications and quality standards
Design, develop, and manage tooling and fixtures. Coordinate quotes and procurement of new tooling with vendors. Assess and execute validation requirements accordingly
Support the maintenance of equipment and tooling once released to production through troubleshooting, repair tracking, and analysis of impact to the validated state
Introduce and support new equipment, products, and processes utilizing industry standard project management tools and techniques
Develop an understanding of current manufacturing processes and identify targets for improvement in data collection/trending, work order transaction processes, and operational efficiencies
Lead process improvement projects through Designed Experiments (DOE’s), structured problem solving (Lean A3, Six Sigma DMAIC), and Statistical Analysis
Ensure data and documentation are consistently accurate and complete
Applies statistical methods to estimate future manufacturing requirements and potential
Analyzes and plans workforce utilization, space requirements, and workflow, and designs layout of equipment and workspace for maximum efficiency utilizing lean techniques when feasible
Estimates production times, staffing requirements, and related costs to provide information for management decisions.Develop sampling procedures, forms, and instructions for recording, evaluating, and reporting quality and reliability data
Remain current with ISO/FDA/ASTM standards and internal quality assurance policies. Support Audits as the process subject matter expert
May supervise Technician, Engineering, Prototype or Programming personnel
Qualification
Required
B.S. in Engineering required; preferably in Mechanical, Electrical, Chemical, or Computer Engineering
Minimum of 12 Yrs. experience in Design and Development or Manufacturing Engineering required
Proven Experience leading process improvement projects
Proven Experience leading new equipment, capital projects
Experience leading/ supervising direct reports
Expert knowledge of Materials and relevant Machine design/function
Proficiency in Industry Standard (ASTM) Test Methods
Proficiency in compliance with ISO regulations and FDA 21 CFR Part 820 with ability to assess and mitigate business and regulatory risks
Preferred
Masters Degree in Engineering or Business preferred
Experience in medical device manufacturing or other health sciences industry preferred
SAP, miniTab, Solidworks experience preferred
Lean Six Sigma Green Belt / Black Belt certification preferred
Benefits
Medical, Dental and Vision Insurance
Company-Provided Life Insurance
Voluntary Life Insurance
Flexible Spending Account (FSA)
Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
Matching 401(k) Retirement Plan
Annual Bonus
Wellness Incentive Program
Free Onsite Medical Clinics
Free Onsite Lunch
Tuition Reimbursement Program
Trip of a Lifetime
Paid Parental Leave
Paid Time Off
Volunteer PTO
Employee Assistance Provider (EAP)
Company
Arthrex
Arthrex is a global medical device company and leader in new product development and medical education in orthopedics.
10001+ employees
H1B Sponsorship
Arthrex 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 (30)
2024 (22)
2023 (13)
2022 (13)
2021 (9)
2020 (12)
Funding
Current Stage
Late StageLeadership Team
Eric Butler
Sr. Director - Surgical Imaging & Integration
Kazu Miyahara
Senior Engineering Manager
Recent News
2025-12-24
Company data provided by crunchbase