Staff New Product Development Engineer

Swan EndoSurgical Inc.; Canton (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Swan EndoSurgical Inc. is seeking a New Product Development Engineer to support the development of complex surgical robotic equipment.

This on-site role emphasizes hands-on assembly, design transfer, and close collaboration with multi-disciplinary teams to accelerate build cycles and readiness for early clinical and pre-commercial phases. The ideal candidate has hands-on mechanical and electrical experience, strong GD&T knowledge, and the ability to resolve difficult technical challenges while

Qualifications

• Bachelor’s degree in engineering and 7+ years in mechanical/electro-mechanical or electro-optical medical devices.
• Experience applying DFM/ DFA/ DTC concepts to manufacturing processes.
• Experience collaborating with external suppliers and vendors.
• Knowledge of GD&T and universal drawing standards.
• Ability to read engineering drawings, wiring diagrams, and CAD models.

Responsibilities

• Apply engineering principles and manufacturing techniques to resolve complex challenges.
• Lead discussions between Design and Supplier to develop robust manufacturing processes.
• Serve as liaison between Operations, R&D, Quality and suppliers.
• Provide manufacturing input to ensure designs support DFM/A and Lean principles.
• Lead Design Transfer activities from R&D to manufacturing including verification and validation.
• Develop and execute IQ/OQ/PQ protocols for equipment and processes.
• Support hands-on assembly and sub-system integration in lab/build environments.
• Maintain design control and risk management documentation for regulatory submissions.

Skills

Mechanical assembly

Electrical assembly

GD&T

Drawing interpretation

CAD models

Education

B.S. in Mechanical/Electrical/biomedical engineering

Tools

Test equipment

Data collection tools

Regulatory documentation

Job description

We are seeking a New Product Development Engineer (NPD) to support the development of complex surgical robotic equipment. This role will make vital contributions in support of robust component designs and directly support the execution of engineering builds, device assembly, testing, and troubleshooting activities to support key development builds and ensure readiness for early clinical and pre-commercial phases. This position places an emphasis on working closely with multi-disciplinary engineering teams to develop sophisticated medical devices. Candidates must be self-motivated, independent and have an eagerness to learn and work as a team, and a desire to thrive in a dynamic environment. In this position, you are expected to demonstrate sophisticated electrical and mechanical engineering knowledge, be able to independently resolve approaches to difficult technical problems and communicate broadly across engineering teams and associated management. This is a hands-on role working closely with engineering to accelerate build cycles and enable rapid iteration. This is an on-site role requiring regular presence in the lab and build environment.

About the Role

Work with internal and external partners to plan, design, develop, qualify, validate, and stabilize component and equipment development process solutions for New Product Development (NPD) projects.

Responsibilities

• Apply engineering principles, world-class manufacturing techniques, statistics, and judgment to resolve complex technical challenges, establish new methods, controls, and procedures.
• Lead discussions between Design and Supplier to select and develop robust manufacturing process using Design for Manufacturing (DFM), Design for Assembly (DFA), Design to Cost (DTC), Design for Metrology tools and associated documentation including specifications, PFMEA, and Control Plans.
• Act as the liaison between Operations, R&D, and Quality as well as component & equipment suppliers.
• Provide "voice of manufacturing" to ensure product/equipment designs incorporate DFM/A principals and/or Lean Six Sigma/DMAIC/DMADV process knowledge.
• Lead and support Design Transfer from R&D to manufacturing including verification and validation activities, Test Method Development (TMD) and Test Method Validation (TMV).
• Implement development engineering standards to support continuous improvement initiatives.
• Support hands-on assembly of engineering builds, including mechanical, electrical, and sub-system integration.
• Define, write, and execute IQ/OQ/PQ protocols to verify equipment/process capability.
• Perform system-level and sub-system troubleshooting, identifying issues and supporting root cause resolution.
• Maintain documentation: design control, risk management, technical records for regulatory submissions, including Device Master Records (DMR).
• Prepare BOMs Identify required equipment, fixtures, tools; work with suppliers and vendors to verify quality.
• Other duties as assigned.

Qualifications

• Minimum B.S (Mechanical, Electrical, Bio-Mechanical or other related Engineering field equivalent) and 7 years industry experience.
• Engineering experience in either mechanical, electro-mechanical, or electro-optical products and medical component development.
• Experience in the areas of Design for Manufacturing or Assembly (DFM&A).
• Experience working closely with external or third-party suppliers.
• Knowledge and application of GD&T and similar universal drawing standards.
• Measurement Systems Analysis experience (e.g., GR&R).
• Statistical Analysis knowledge (e.g., Design of Experiments (DOE), Process Stability/Control/Capability).
• Understand equipment concept creation, review approval, build, run off, FAT, software validation, and IQ, OQ, PQ road map requirements.
• Proven interpersonal and communication skills, with the ability to work successfully in a team environment.
• Strong technical communication skills and proven ability to work independently.
• Hands-on experience with mechanical and electrical assembly and system integration in lab or machine shop environments.
• Ability to read engineering drawings, wiring diagrams, and work instructions.
• Experience working from early-stage designs, drawings, or CAD models where processes and documentation are not yet fully defined.
• Strong attention to detail and ability to follow processes and documentation requirements.

Required Skills

• Technical Skills: Hands-on mechanical and electrical assembly skills; ability to read and interpret engineering drawings (GD&T), schematics, and CAD models.
• Analytical Skills: Ability to troubleshoot and identify issues in electromechanical systems.
• Communication Skills: Clear communication of issues, progress, and build status to engineering teams.
• Teamwork: Ability to work collaboratively in a cross-functional, fast-paced environment.
• Adaptability: Comfortable working in a dynamic environment with changing priorities and evolving processes.

Preferred Skills

• Experience supporting engineering builds in medical devices, robotics, or capital equipment environments.
• Endoscope, laparoscope, reusable, and consumable instruments or device experience.
• Familiarity with regulated environments and basic documentation practices (e.g., DHR, DMR).
• Experience with test equipment and data collection tools.
• Basic understanding of manufacturing processes and continuous improvement principles.
• Advanced Degree a plus.

Pay range and compensation package

This is a hybrid role and requires regular presence in the office and lab environment, with some flexibility. This position operates in a professional office and lab environment. The work setting is fast-paced and energetic. The role includes significant time in lab or build environments supporting hands-on system assembly, integration, and troubleshooting. The role may involve extended periods of standing, manual assembly work, and regular use of hand tools and test equipment. The role may involve extended periods of sitting, regular computer use, and occasional meetings, with flexibility in working hours to support critical builds and program milestones.

Equal Opportunity Statement

We are committed to diversity and inclusivity.