We are not working with any third-party vendors or on a C2C basis.
Please note: This position is on-site in Morrisville, NC. This role cannot be remote.
NIRSense is unable to provide current or future employment visa sponsorship for this position. Candidates must be authorized to work in the United States without employer sponsorship.
About the Company:
NIRSense is a world-leading non-invasive patient monitor developer. Our tools measure oxygenation changes in the body 10x deeper than typical pulse oximetry and track the electrophysiological activity of muscles and the brain. We are particularly focused on new-to-the-world sensors that can be used and applied in rugged environments. We are a growing team of technology developers, and we are seeking candidates interested in helping advance our capabilities for a wide range of interested stakeholders who are driven to transform the way humans understand and interact with their own health.
Job Summary:
NIRSense is seeking a Senior Mechanical Engineer with a minimum of eight years of directly relevant industry experience in medical device and/or wearable product development to work alongside our growing engineering and scientific team in its Morrisville, NC office.
This is a senior-level position requiring demonstrated experience developing complex mechanical systems and taking products from early-stage design and prototyping through design verification, manufacturing readiness, and production scale-up. The successful candidate will have significant hands-on experience designing mechanical components and systems for medical devices or wearable technologies and working within a regulated product-development environment.
This person will lead a broad set of development objectives for NIRSense's many customers. They will integrate with a team of mechanical engineers, manage project requirements for NIRSense systems and their mechanical designs, and track and resolve open issues with NIRSense hardware designs. The ideal candidate is an experienced professional looking to apply their skills toward advancing NIRSense's transformational capabilities and who works well in a fast-paced, high-performance team.
Key Responsibilities:
- Lead mechanical design and development activities for NIRSense systems, wearable devices, and related hardware.
- Develop mechanical designs for rigid and flexible enclosures, molds, test fixtures, optical interfaces, and other product components using SolidWorks.
- Translate system and product requirements into mechanical designs that meet performance, usability, safety, and manufacturability requirements.
- Lead and support the development of prototypes and their progression toward production-ready designs.
- Identify, track, troubleshoot, and resolve mechanical and hardware design issues throughout the product development lifecycle.
- Develop and evaluate rapid prototypes, fixtures, molds, and prototype subassemblies to support product development and testing.
- Apply Design for Manufacturing (DFM), Design for Assembly (DFA), and Design for Test (DFT) principles to mechanical designs.
- Collaborate closely with electrical, firmware, software, scientific, manufacturing, and other engineering team members to ensure successful system integration.
- Support design verification and validation activities and ensure mechanical designs meet applicable product requirements.
- Develop and maintain mechanical design documentation, specifications, drawings, and other technical records.
- Support the transition of new designs from R&D and prototyping into repeatable manufacturing processes.
- Work within NIRSense's quality management system and applicable medical device regulatory requirements.
- Provide technical leadership, sound engineering judgment, and hands-on problem-solving across multiple development programs.
Minimum Qualifications:
- B.S. or M.S. in Mechanical Engineering, Biomedical Engineering, or a related field.
- Minimum of eight years of professional, post-graduate mechanical engineering experience, including substantial experience designing and developing medical devices and/or wearable products.
- Demonstrated experience leading mechanical design activities for complex products through multiple stages of the product development lifecycle.
- Advanced proficiency with SolidWorks, with demonstrated professional experience designing rigid and/or flexible enclosures, molds, test fixtures, optical interfaces, and mechanical assemblies.
- Strong knowledge of safety, performance, and regulatory compliance requirements for medical devices, including IEC 60601, ISO 10993, ISO 13485, ISO 14971, IEC 62366, and related FDA guidance.
- Demonstrated experience taking products from prototype through design verification, manufacturing readiness, and production scale-up.
- Experience with rapid prototyping processes, including creating fixtures, molds, and prototype subassemblies.
- Familiarity with Design for Manufacturing (DFM), Design for Assembly (DFA), and Design for Test (DFT) practices.
- Ability to independently identify and resolve complex mechanical design and system integration challenges.
- Strong technical communication and documentation skills with the ability to collaborate effectively across multidisciplinary engineering teams.
Preferred Qualifications:
- Experience designing waterproof and corrosion-resistant products.
- Design experience with systems interfacing with the human body.
- Experience developing wearable medical devices or other products intended for direct and prolonged contact with the human body.
- Experience working in a fast-paced R&D, new product introduction (NPI), or medical device development environment.
- Experience supporting products through design transfer and manufacturing scale-up.