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.
- 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, 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 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. 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
