Manager, Process Engineering

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

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 through project hand off, including validation/commissioning, with the goal of optimizing asset life 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 MDR, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory agencies.

Job 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)

Skills & Competencies

* 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…