Integra LifeSciences · 7 hours ago
Process Engineering Manager
Integra LifeSciences is a company focused on creating change and shaping the future of healthcare. The Process Engineering Manager is responsible for the technical leadership of the Medical value stream's equipment and processes, ensuring compliance with regulations and driving improvements in quality and productivity.
BiotechnologyMedical DeviceHealthcareLife ScienceHealth CareMedical
Responsibilities
Ensure the safety of colleagues through effective and continuously improving environmental, health, and safety program engagement. Ensure all team members receive training, and are knowledgeable and compliant regarding safety procedures, policies, permits, practices, PPE, proper housekeeping, and awareness. Initiates and lead accident, near miss, and incident investigations
Lead team supporting production line operations including new products, product and process transfers, equipment qualifications, process validations, process efficiency improvements, and quality and supply issues resolutions
Lead, coach, and develop a team of engineers and technicians staffing, training, attendance, overtime, operational issues, talent management, performance management, development planning and reporting of results
Oversee team develop and implement engineering studies as necessary, specifications and drawings, engineering change orders (ECO), Non-conformances (NC's), Corrective And Preventative Actions (CAPA), Failure Mode Effects Analysis (FMEA), validations (IQ, OQ, PQ, PV, TMV, etc)
Ensure project planning and execution protects the identity, quality, durability, reliability, safety, and effectiveness of medical devices and, thereby, protects patient safety
Perform timely technical investigations and provide practical manufacturing solutions, under appropriate regulatory guidelines for a medical device manufacturer. Ensure team conducts timely and effective non-conformance, investigations, and Corrective and Preventive Action(s) (CAPA)
Partner with the cross-functional teams to meet customer fulfillment needs as well as lead process optimization, yield improvement, six sigma process excellence and lean projects. Monitor process capability and performance metrics (CoPQ, Cpk, yield, run time, downtime, scrap). Develop process/project improvement and mitigation projects to improve capability and performance
Ensure value stream cost of goods sold (COGS) results are in line with financial targets by ensuring bill-of-materials (BOMS), routers, and process instructions align to costs. Accountable for all department financial budgets (headcount, expense, capital, inventory)
Complete other job-related duties as assigned
Qualification
Required
Engineering or Technical degree with 8+ years of experience leading a team (direct reports or projects) or equivalent education and years of management experience OR Master degree with 5+ years of experience leading a team (direct reports or projects) or equivalent education and years of management experience
Demonstrate excellent organizational and english communication skills (oral & written)
Financial acumen relating to investment opportunities, continuous improvement P&L impacts, etc
Proficiency in MS Office Suite and statistical analysis software
Experience in regulated environment; medical device or pharma preferred
Familiarity with health, safety, and environmental regulations related to manufacturing
Self-motivated team player with ability to work independently and collaboratively across all levels of the organization
Preferred
Experience in regulated environment; medical device or pharma preferred
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Savings plan (401(k))
Company
Integra LifeSciences
Integra LifeSciences is an integrated medical device company.
H1B Sponsorship
Integra LifeSciences 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 (4)
2024 (5)
2023 (4)
2022 (7)
2021 (5)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
$350M2018-05-15Post Ipo Equity· $350M
1995-08-25IPO
Recent News
EIN Presswire
2026-02-02
2026-01-23
Company data provided by crunchbase