Sr. Project Engineer II

Integra LifeSciences; Mansfield (MA); On-site; USD 94,000 - 130,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

401(k)

Job summary

Integra LifeSciences is seeking a Senior Project Engineer II - Utilities & Equipment to lead cross-functional engineering initiatives for medical devices, from concept through launch, ensuring regulatory and quality compliance.

The role requires experience with GMP, ISO 9001/13485, and regulatory standards (FDA, EU MDR). Strong leadership, problem solving, and communication in English are essential.

Qualifications

• 8+ years of engineering experience or a Master’s degree with 3+ years of experience.
• Experience with statistical process control tools (SPC, Minitab, other software) required.
• Lean Six Sigma experience required.

Responsibilities

• Develop cross-functional networks to execute projects across facilities, equipment, and processes.
• Lead strategic site and enterprise projects addressing quality improvements and lifecycle management.
• Prepare engineering studies, IQ/OQ/PQ/TMV validations, and engineering change requests.

Skills

SPC

Lean Six Sigma

Project management

English communication

ERP knowledge

Education

Bachelor’s degree in engineering or equivalent

Master’s degree in engineering or related field

Tools

SAP

MS Project

Jira

MS Office

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.

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

Relevant Tools & Equipment

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.

Benefits

• 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

Equal Opportunity Employment

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].