Sr. Project Engineer II

INTEGRA LIFESCIENCES PRODUCTION CORPORATION; Mansfield (MA); On-site; USD 94,000 - 130,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Life insurance

Short/long-term disability

401(k) retirement plan

Job summary

Integra LifeSciences is seeking a Senior Project Engineer II - Utilities & Equipment in the United States to lead cross‑functional engineering initiatives spanning facilities, equipment, and processes for medical device development under GMP/ISO regulations.

You will drive end‑to‑end projects from concept through validation to launch, mentor teams, and ensure compliance with FDA, ISO 9001/13485, EU MDR, CMDR, and related standards while coordinating with product development and regulatory groups.

Qualifications

• SPC tools and statistical analysis experience required.
• Lean Six Sigma experience essential.
• Strong organizational and English communication skills.
• PM experience and PMP is desirable.
• ERP/CRM usage and MS Office proficiency required.

Responsibilities

• Develop cross‑functional network across EHS, site teams, and manufacturing to execute projects.
• Lead strategic site and enterprise projects addressing quality improvements and lifecycle management.
• Plan and implement IQ/OQ/PQ/TMV validations and engineering changes.
• Analyze process parameters to improve yields and reduce scrap using lean methods.
• Lead CAPA investigations and risk mitigation in collaboration with QA/regulatory.
• Manage budgets, resources, and transfer new products to manufacturing.

Skills

SPC tools

Lean Six Sigma

English communication

Project management

MS Office

Education

Bachelor’s degree in engineering or equivalent

Master’s degree in engineering or related field

Tools

SAP ERP

CRM platforms

MS Project

Jira

Excel

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 Senior Project Engineer II - Utilities & Equipment leads cross‑functional engineering initiatives to design, develop, validate, and commercialize medical devices in compliance with regulatory and quality requirements. This role is responsible for end‑to‑end project execution—from concept feasibility through product launch—ensuring that technical objectives, timelines, and quality standards are met. The Senior Project Engineer acts as a technical leader, problem‑solver, and liaison between engineering, manufacturing, quality, regulatory, suppliers, and external partners. They plan and execute 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.

REPORTING & MANAGEMENT SCOPE SUPERVISION RECEIVED

Under direct supervision of the Engineering Manager

KEY RESPONSIBILITIES

• Develop cross-functional network with Environmental, Health, and Safety (EHS), site value stream teams, product development, process technology, Centers of Excellence (CoE's), facilities, quality, regulatory, planning, procurement to execute projects to support facilities, equipment, and process changes.
• Assist in strategic site and enterprise projects on cross-functional teams addressing quality improvements, lifecycle management efforts, new product introductions, etc.
• Initiate, develop and implement engineering studies, IQ/OQ/PQ/TMV validations, manufacturing process requirements, specifications, Engineering Change Requests/Orders (ECR/ECO), and Engineering Drawings for equipment, processes and facilities.
• Leverage 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.
• Perform timely technical investigations, non-conformance, Failure Mode Effects Analysis (FMEA), and Corrective and Preventive Action (CAPA).
• Identify, financially justify, and lead projects to drive process, quality, reliability and cost improvements leveraging advanced technologies, lean six-sigma tools and methodologies.
• Leverage project management tools/techniques/methods manage projects in their entirety including scheduling, resource forecasting, and financial budgeting.
• Partner with product development to develop prototypes, specifications, manufacturing processes, and equipment to transfer new and/or improved products to manufacturing.
• Track and financial project budgets including labor, expense, capital, scrap, inventory, and risk.
• Develop hands‑on product/process/equipment training programs.
• Lead cross-functional process and product project teams including suppliers, product development, quality assurance, facilities, regulatory, and manufacturing.
• Complete other job‑related duties as assigned.

Skills & Competencies

• A Bachelor’s degree in engineering or equivalent with 8+ years of experience or Master’s degree with 3+ years of experience.
• Experience with statistical process control tools required (SPC, Minitab, other software) required.
• Lean Six Sigma experience required.
• Demonstrate excellent organizational and English communication skills (oral & written).
• Project management and process improvement experience, PMP desired.
• Knowledge in enterprise resource planning, material resource planning, and MS Office skills.

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.

Salary Pay Range: $94,300.00 - $129,950.00 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
• group legal insurance
• 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 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].

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.

Integra - Employer Branding from Integra LifeSciences on Vimeo

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.