The
Project Engineer II 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 SCOPESUPERVISION 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 REQUIREMENTSThe 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 trainingIn addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensationYour 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
