Manager, Process Engineering – Collagen/Lyo Value Stream

Integra LifeSciences•US-PR-Anasco-165-Facility, PR

14d•$73,000 - $102,000•Onsite

About The Position

The Process Engineering Manager is responsible for the technical and leadership of the site value stream's equipment and processes. They are responsible for end-to-end process and product understanding and control, managing lifecycle management and sustaining engineering changes, and driving improvements in quality, productivity, and yield. They are responsible for multidisciplinary project definition from project hand off, including validation/commissioning, with the goal of optimizing asset lite cycle management and sustainability by using good engineering practices in support of supply chain integrity. They ensure the planning and execution of their duties in compliance with corporate policies, U.S. Food and Drug Administration regulations, Good Manufacturing practices (GMP), ISO 9001, ISO 13485, EU MOR, the Canadian Medical Device Regulations (CMDR), and ofher applicable regulatory agencies.

Requirements

Engineering or Technical degree with 5+ years of experience leading a team (direct reports or projects) or equivalent education and years of management experience or master's degree with 3+ years of experience leading a team (direct 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.
Experience in regulated environment; medical device or pharma preferred.
Self-motivated team player with ability to work independently and collaboratively across all levels of the organization.

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 accidents, near miss, and incident investigations.
Lead team supporting production line operations including new products, and process transfers, equipment qualifications, process validations, process efficiency improvements, and quality and supply issues resolutions.
Lead 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 projects the identity, quality, durability, reliability, safety, and effectiveness of medical devices and, thereby, projects patient safety.
Performs timely technical investigations and provides practical manufacturing solutions, under appropriate regulatory guidelines for a medical device manufacturer. Ensure team conducts timely and effective non-conformances, 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 end performance metrics (CoPQ, Cpk, yield, run time, downtime, scrap). Develop 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.