Staff New Product Introduction Engineer

Job Description

Job Description

Job Title: Staff New Product Introduction (NPI) Engineer

Manager: Director of Advance Manufacturing (Capital)

Job Summary:

We are seeking a Staff New Product Introduction (NPI) Engineer to support the industrialization and manufacturing readiness of complex surgical robotic equipment. This role will work closely with cross-functional engineering teams to develop robust manufacturing processes, support engineering builds, and transition products from development into controlled, repeatable manufacturing operations.

The Staff NPI Engineer will independently lead assigned NPI activities, including manufacturing process development, build execution, and manufacturing readiness, while collaborating with the Principal Manufacturing Engineer on key technical decisions and manufacturing strategies.

This is a hands-on role requiring strong mechanical and electrical engineering knowledge, independent problem-solving, and close collaboration with R&D, Quality, Operations, and suppliers.

What You’ll Do:

• Develop, implement, and optimize manufacturing processes for complex electromechanical systems, including assembly, integration, inspection, and testing.
• Lead assigned NPI activities independently, working with the Principal Manufacturing Engineer to ensure alignment on key technical decisions and manufacturing strategies.
• Drive DFM/DFA discussions with R&D and suppliers to improve manufacturability, assembly efficiency, quality, and cost.
• Support hands-on engineering and pilot builds, including mechanical and electrical assembly, system integration, troubleshooting, and root cause resolution.
• Support design transfer activities, including manufacturing readiness assessments, process verification, validation, and documentation.
• Develop manufacturing documentation, including work instructions, assembly procedures, process specifications, PFMEAs, Control Plans, and manufacturing BOMs.
• Identify manufacturing equipment, tooling, and fixture requirements, working with internal teams and suppliers to develop and implement solutions.
• Support manufacturing readiness, including material availability, supplier readiness, tooling, equipment, and build execution.
• Identify and resolve manufacturing risks and technical challenges to support program milestones.
• Support equipment qualification, process validation, and continuous improvement initiatives as applicable.

Skills and Abilities:

• Technical Skills: Strong understanding of manufacturing process development, mechanical and electrical assembly, DFM/DFA, and design transfer. Ability to interpret engineering drawings, GD&T, schematics, and CAD models.
• Analytical Skills: Ability to independently troubleshoot complex electromechanical systems, analyze manufacturing challenges, identify root causes, and develop effective technical solutions.
• Communication Skills: Strong verbal and written communication skills, including the ability to clearly communicate technical issues, manufacturing readiness, and project status across engineering teams and management.
• Teamwork: Ability to collaborate effectively with R&D, Quality, Operations, and suppliers while independently leading assigned NPI activities and aligning with broader technical strategies.
• Adaptability: Ability to work effectively in a fast-paced development environment with evolving designs, changing priorities, and emerging manufacturing requirements.

What you Bring:

Required:

• Bachelor's degree in Mechanical, Electrical, Biomedical, or a related engineering field with a minimum of 7 years of relevant engineering experience.
• Experience in manufacturing engineering, NPI, or manufacturing process development for mechanical, electromechanical, or electro-optical products.
• Hands-on experience with mechanical and electrical assembly, system integration, and troubleshooting.
• Experience with DFM/DFA, GD&T, and interpreting engineering drawings and CAD models.
• Experience developing manufacturing processes, assembly procedures, work instructions, tooling, and fixtures.
• Experience supporting engineering builds, manufacturing readiness, or design transfer activities.
• Demonstrated ability to independently lead assigned technical activities and collaborate across R&D, Quality, Operations, and suppliers.

Preferred:

• Experience with medical devices, robotics, or complex capital equipment.
• Experience with regulated manufacturing environments and documentation requirements (DMR/DHR).
• Experience with PFMEAs, Control Plans, and manufacturing risk management.
• Experience with process validation and equipment qualification (FAT, IQ/OQ/PQ).
• Knowledge of statistical methods, including GR&R, DOE, and process capability analysis.
• Experience with test method development and validation.
• Advanced degree in a related engineering field.

Work Environment:

• Travel requirement: Typically less than 10%
• This is a primarily on-site position requiring regular presence in the engineering lab and manufacturing build environment, with flexibility based on program and business needs.
• The role involves hands-on assembly, integration, testing, and troubleshooting, including regular use of hand tools and test equipment.
• This position operates in a professional office environment.
• The work setting fast paced and energetic.
• Employees typically work at a desk or workstation using standard office equipment such as computers, phones, printers, and collaboration tools.
• The role may involve extended periods of sitting, regular use of a computer, and occasional meetings—both in person and virtual.

We are committed to providing reasonable accommodations for qualified individuals with disabilities in our job application and interview process. If you need an accommodation to apply, interview, or perform the essential functions of this role, please contact [nancy.lebeau@swansurg.com] before the scheduled interview. All requests will be handled confidentially in accordance with the Americans with Disabilities Act (ADA) and Massachusetts disability laws