Senior Manufacturing Engineer

Position Summary

The Senior Manufacturing Engineer leads the development, optimization, and implementation of manufacturing processes. This role is critical in driving operational excellence, improving product quality, and ensuring efficient production workflows. The ideal candidate will have a strong background in manufacturing engineering, problem-solving, and cross-functional collaboration to enhance overall productivity and meet business goals.

Responsibilities/Duties

Process Development and Optimization:

• Design and implement manufacturing processes that improve efficiency, reduce costs, and meet quality standards.

• Analyze existing workflows and identify opportunities for automation, standardization, and waste reduction.

• Collaborate with design and R&D teams to ensure manufacturability of new products.

• Hands-on process design, development, validation, and manufacturing transfer. 

• Develop test methods and author process validation protocols and reports.

• Author and release equipment installation and operation qualifications. 

• Collaborate with engineering to develop, document, and build prototypes, tooling, and fixtures to produce vascular medical devices according to design, quality specifications, and budget. 

Technical Leadership:

• Provide technical expertise and guidance to resolve complex manufacturing issues.

• Lead troubleshooting and root cause analysis for process and equipment failures.

• Lead manufacturing start-up projects.

• Potential to manage team of technicians.

• Effectively communicate and collaborate with cross functional teams including; quality, R&D, management. 

Project Management:

• Plan and manage manufacturing projects, ensuring timely delivery and alignment with organizational goals.

• Coordinate with cross-functional teams, including operations and quality.

• Monitor project performance, adjusting strategies as needed to achieve desired outcomes.

• Track material lead times, scrap rates, and product delivery schedules.

• Support product transfer from R&D to pilot production and full production through training and process development. 

• Interact with outside vendors including third-party sterilizers and contract testing labs in order to accomplish project deliverables.

Quality and Compliance:

• Ensure all processes comply with company standards, regulatory requirements, and industry best practices.

• Partner with the quality team to implement and maintain robust quality control measures.

• Maintain lab notebook practices and GMP in accordance with company quality procedures.

• Support and manage product development and manufacturing efforts including; product testing, recording and analyzing data, writing procedures and reports.

Continuous Improvement:

• Drive a culture of continuous improvement using Lean, Six Sigma, or other methodologies.

• Monitor production data to identify trends and implement corrective actions proactively.

• Implement cost reductions by working closely with production to reduce scrap and waste and improve efficiencies

Additional duties as required

Minimum Qualifications, Education, and Experience Required

Education & Experience

● Bachelor’s degree in Mechanical, Industrial, Manufacturing Engineering, or a related field

● 8 years of experience in manufacturing engineering, with a proven track record of process improvement and successful project delivery.

● Knowledge of medical device testing and FDA requirements is highly preferred.

● Proficiency in CAD software, ERP systems, and manufacturing tools.

● Strong knowledge of Lean manufacturing principles and Six Sigma methodologies (certification is a plus).

● Project Management skills

● Knowledge of manufacturing methods for vascular catheter systems is highly preferred

● Lean manufacturing training and experience preferred

● Familiarity with statistical process control and metrology

Abilities

● Process orientation mindset with strong communication and presentation skills, persistence and discipline, and a drive for results

● Must possess excellent organizational, problem-solving, analytical, interpersonal, communication, and computer skills to effectively utilize ERP systems and Microsoft Office products

● Self-starter, ability to prioritize work and work independently

● Ability to manage multiple projects and work effectively in a team-oriented environment.

● Must be able to travel 10-15% domestically and internationally

● Ability to use equipment such as a microscope, soldering iron, cutters, and various hand tools.

Work Conditions:

Work is performed primarily in a standard office environment and manufacturing setting.  Essential functions require sufficient physical ability and mobility to work in an office and manufacturing setting; to stand or sit for prolonged periods of time; to bend, kneel and reach; to lift, carry, push/pull light to moderate amounts of weight; to operate office equipment that may require fine motor coordination (i.e., use of a keyboard).  Reasonable accommodations may be made when an employee has a qualified disability but can still perform the essential functions of the job (without creating an undue hardship).