Manager, Process Engineering – Collagen/Lyo Value Stream

Reporting & Management Scope

Under direct supervision of the Value Stream Manager. Position will directly manage a team of process engineers and technicians.

Key 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 and 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.

Skills & Competencies

• 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.
• Self-motivated team player with ability to work independently and collaboratively across all levels of the organization.