Senior Manufacturing Engineer

3 weeks ago

Boston, United States Integra LifeSciences Full time
Integra LifeSciences Senior Manufacturing Engineer Boston, Massachusetts Apply Now

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 Manufacturing Engineer will lead and support engineering projects and operations focused on the development, and optimization of manufacturing processes for high-quality production. This role requires technical expertise, cross-functional collaboration, and leadership in troubleshooting, process improvements, and validation activities to ensure production efficiency and regulatory compliance in a medical devices regulated industry. The Senior Manufacturing Engineer will be responsible for identifying opportunities for cost reduction, quality improvements, and process efficiency while ensuring alignment with safety and quality standards.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  1. Provide technical leadership in the design, validation, and troubleshooting of production equipment and processes.
  2. Develop, specify, purchase, and maintain manufacturing equipment, automation, tooling, and fixtures to support production needs.
  3. Create and execute engineering protocols for IQ, OQ, and PQ to ensure equipment and processes meet regulatory and performance standards.
  4. Lead test method development protocol and execution.
  5. Write and implement manufacturing procedures and work instructions to standardize processes, ensure quality control, and optimize production workflows.
  6. Act as a recognized technical expert, providing process and equipment engineering expertise to resolve manufacturing-related issues for existing products and processes.
  7. Lead and/or support change controls (ECOs), CAPAs, and NCs to address manufacturing and quality process issues.
  8. Own NC's and CAPAs driving completion in a timely and compliant manner.
  9. Drive process improvement initiatives, utilizing Lean or Six Sigma methodologies to optimize processes, reduce costs, improve quality, and minimize waste.
  10. Collaborate with R&D, Quality, and Operations teams to design and implement efficient and scalable manufacturing processes.
  11. Ensure compliance with industry standards and regulations (e.g., ISO, FDA) in manufacturing processes.
  12. Mentor and train junior engineers and production staff, sharing best practices and technical expertise to improve team capabilities.

BASIC QUALIFICATIONS

  1. Bachelor's degree in engineering (Mechanical, Industrial, or related field) with 5+ years of experience or equivalent education and years of experience; Doctoral degree with 0-2 years of experience or equivalent education and years of experience.
  2. Experience in a regulated industry such as medical devices or pharmaceuticals.
  3. Strong experience with validation protocols (IQ, OQ, PQ) and equipment/process qualifications.
  4. Proven expertise in Lean Manufacturing, Six Sigma, and other process improvement methodologies; Six Sigma Green Belt or Black Belt certification from a reputable institution preferred.
  5. 2+ years of experience in CAPA/NC investigations with a strong understanding of root cause analysis and corrective action processes.
  6. Proven experience in project management, including balancing project scope, schedule, and cost in a fast-paced manufacturing environment.
  7. Excellent problem-solving and leadership skills, with the ability to manage multiple projects concurrently.
  8. Strong communication, team-building, and cross-functional coordination skills, with experience working in cross-functional teams.

PREFERRED QUALIFICATIONS

  1. Master's degree in engineering, business, or a related field with 3+ years of experience or equivalent education and years of experience.
  2. Proficiency in CAD or process simulation software (e.g., AutoCAD, SolidWorks, or similar tools).
  3. Experience with statistical process control (SPC) and advanced data analysis tools (e.g., Minitab, JMP).
  4. Hands-on experience in FDA remediation projects, including addressing regulatory findings and implementing corrective and preventive actions (CAPA) to ensure ongoing compliance.
  5. Experience in manufacturing line transfer and relocation, including the planning, execution, and validation of equipment and processes at new production sites.
  6. Certification in Project Management (e.g., PMP or equivalent).
  7. Experience in biologics, organics, or human tissue processing.

TOOLS AND EQUIPMENT USED

Ability to utilize a computer, telephone, smartphone as well as other general office equipment.

PHYSICAL REQUIREMENTS

The physical requirements listed in this section include, but are not limited to, the motor/physical abilities and skills required of position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.

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