Engineering Manager, Mansfield

Integra LifeSciences•Mansfield, MA

1d•Onsite

About The Position

The Engineering Manager is responsible for the technical and operational leadership of the Integra's site facilities, utilities, equipment, and capital projects in the GMP manufacturing, laboratory, support, and non-GMP spaces of the manufacturing site. Under the direction of the Plant Manager this Engineering Manager will be responsible for multidisciplinary project definition through project hand-off, including validation/commissioning, with the goal of optimizing asset life cycle management and sustainability using good engineering practices in support of supply chain integrity. They ensure the planning and execution of their duties are 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.

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 degree with 3+ 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 operations profit & loss (P&L) items
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.

Nice To Haves

Experience in regulated environment; medical device or pharma preferred

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 leads accident, near miss, and incident event notifications.
Lead, coach, and develop a team of supervisors, managers, engineers, and technicians.
Responsible for managing staffing, training and daily maintenance operations across shifts up to 7 days a week, including attendance, overtime, operational issues, talent management, performance management, development planning and reporting of results.
Partner with the value stream teams to meet customer fulfillment needs as well as lead process optimization, yield improvement, six sigma process excellence and lean projects.
Partner with product development (R&D), regulatory, and quality teams to develop, qualify, and validate new products and processes to meet business needs.
Serve as a member of the site leadership team participating in strategic and tactical planning & execution to ensure site objectives are met.
Ensure alignment of engineering objectives with overall site objectives.
Oversee team develop and implement engineering studies as necessary, development of manufacturing process requirements, specifications and drawings, engineering change orders (ECO), Failure Mode Effects Analysis (FMEA), validations (IQ, OQ, PQ, PV, TMV, etc).
Oversee projects to implement statistical process control (as necessary), analyze and trend existing process parameters, process inputs and outputs, improve manufacturing yields, reduce manufacturing scrap, and error proof manufacturing processes.
Partner with cross-functional teams to develop capital budgets to meet growth, productivity, and sustainability site goals.
Assess and develop capital plans for production & process equipment replacement and/or addition of new equipment.
Partner with all cross functional departments in equipment selections and facilities designs.
Lead and collaborate with contractors and cross-functional groups across the organization to implement initiatives, projects, and improvements as necessary.
Ensure contractors remain on schedule to milestone plans, deliverables, change orders, risk mitigations, and construction timelines.
Prepare handover package inclusive of plans, as-built drawings, approvals, minutes, and OEM documentation.
Work cross-functionally and collaboratively to solve operational issues.
Interacts with senior management on matters concerning several job areas, departments, and/or customers to accept new concepts, practices and approaches as well as with senior level vendor or customer representatives concerning projects & operational decisions.
Develops, reviews, approves, and accountable for all program budgets within the engineering team, including headcount, expense, capital, and inventory.
Complete other job-related duties as assigned.