Manager, Process Engineering – Collagen/Lyo Value Stream

INTEGRA CI INC; United States; On-site; USD 73,000 - 102,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401(k) Savings plan

Job summary

Integra LifeSciences is seeking a Process Engineering Manager to lead a team of engineers and technicians in a regulated medical device manufacturing setting. You will oversee end-to-end process development, qualifications, and continuous improvement to ensure safety, product quality, and cost targets.

The role requires experience in ECOs, CAPAs, and validations (IQ/OQ/PQ) with strong cross-functional collaboration across engineering, quality, and operations.

Qualifications

• Engineering or technical degree with leadership experience in a regulated manufacturing environment.
• Experience managing a team of engineers and technicians; strong cross-functional collaboration.
• Familiarity with GMP, ISO 9001/13485 and medical device regulations.

Responsibilities

• Lead safety and EHS program engagement across the value stream.
• Oversee training, compliance, and skill development of team members.
• Guide production line operations, transfers, qualifications, and validations.
• Develop staffing plans, performance reviews, and succession planning.
• Manage ECOs, CAPAs, FMEA, IQ/OQ/PQ, and process validations.
• Ensure cost of goods and budgeting alignment with financial targets.
• Collaborate with cross-functional teams to meet customer needs and drive improvements.
• Monitor process capability metrics and drive yield improvements.

Skills

Leadership

Communication (English)

Financial acumen

MS Office

Statistical analysis

Education

Engineering or Technical degree

Tools

SAP

MS Project

Jira

Job description

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 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.

Reporting & Management Scope

SUPERVISION RECEIVED Under direct supervision of the Value Stream Manager

SUPERVISION EXERCISED 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 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.

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.
• 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.

Tools and Equipment Used

• General Office equipment: Computers, printers, copiers, tax 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.

Salary

Salary Pay Range: $73,000.00 - $102,000.00 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.

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)).

Benefits

• 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

Equal Opportunity & Rights

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 by 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 [e-mail].

Company Culture

Whatever your specialty, you’ll find an ideal setting for building a rewarding career. Along the way, you’ll have the satisfaction of knowing your work matters, that it’s making patients’ lives better, making a positive and lasting difference. You’ll find that the pace is exhilarating – because the need is so urgent. You’ll be challenged – and supported – by the most dynamic and inspiring people in your profession. And you’ll grow a career that is more impactful and fulfilling then you thought possible. More than 4,200 Integra employees already know we’re a great place to build a career. Here’s your chance to discover that for yourself.