Engineering Manager

About Us

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.

Summary Description

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.

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 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. They will also 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.

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 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.
• 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.

Tools And Equipment Used

This role requires regular use of tools and equipment relevant to the work environment. Examples include:

• General office equipment: Computers, printers, copiers, fax machines, and telephone communication systems.
• Software and systems: ERP systems (e.g., SAP), CRM platforms, statistical analysis tools, project management software (e.g., MS Project, Jira), QMS platforms.

Physical Requirements

The physical requirements listed below represent the motor and physical abilities necessary to successfully perform the essential duties of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to enable individuals with disabilities to perform these duties.

While performing the responsibilities of this role, the employee is expected to:

• Sit, listen, speak, and move throughout various areas of the building.
• Travel across all company locations as needed.
• Periodically lift and/or move items up to twenty-five pounds.
• Travel domestically and internationally via car, train, or airplane, as required by the role.

ADVERSE WORKING CONDITIONS

The conditions listed below represent environmental factors which the employee may be exposed to while performing the essential duties of this position. These reflect a general plant or service environment.

Adverse exposure may include handling hazardous and biohazardous materials such as:

• Flammable and corrosive liquids
• Compressed gases
• Sharps
• Medical waste

Appropriate safety protocols and personal protective equipment (PPE) are required and provided. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the role.

Salary Pay Range

$109,250.00 - $149,500.00 USD Salary

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Additional Description for Pay Transparency

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

This site is governed solely applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices: EEO Is the Law | EOE including Disability/Protected Veterans

Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com.

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.

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