Biomedical Project Manager Jobs in Raleigh, NC (NOW HIRING)

Title: Mechanical Engineering Manager

Location: Morrisville, NC (On-Site)

Anticipated Start Date: ASAP

About the Company:

NIRSense is a cardiology company focused on developing world-leading non-invasive medical devices. 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 a growing team of technology developers 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 an experienced mechanical engineer to work alongside and manage our growing mechanical and manufacturing engineering team in its Morrisville, NC office. This engineering manager will lead a broad set of development objectives for NIRSense's many customers, focused on the realization and repeatable production of NIRSense hardware, system components, and test fixtures. This manager will lead a team of mechanical engineers, will manage project requirements for NIRSense systems and its mechanical designs, and will track open issues with NIRSense hardware designs. The ideal candidate is an experienced professional looking to apply their skills toward optimizing system interoperability for NIRSense's transformational capabilities. They work well in a fast-paced and high-performance team.

Salary: The compensation package will be commensurate with the successful applicant's experience.

Hours: Full time

Travel: 0-5%

Job Responsibilities:

• Design compact, wearable systems that involve electronic components, rigid-flex PCBs, batteries, RF protection, flexible and rigid system casings, optical windows, displays, buttons, ambient light shields, and biocompatible skin interfacing materials
• Lead a team of mechanical and systems engineers supporting test fixture design, component design, and advanced prototype design, development, and build
• Collaborate with Program Management to understand technical requirements, priorities, and delivers and develop executable plans for the mechanical engineering team to execute
• Serve as the team's technical lead for mechanical engineering decisions.
• Work with the electrical engineering team to integrate PCB components with flexible or rigid enclosure designs that conform to the human body
• Design system protections for operational robustness including water ingress to deep underwater, corrosion protection from salt spray and seawater, and challenging dust, vibration, and thermal environmental requirements
  Collaborate with senior management to develop technology transfer and production strategies
• Design test fixtures, molds, manufacturing jigs, and related subsystems to build, test, and validate prototype systems
• Follow best practices for design controls and quality management systems including version control, configuration management, secure and compliant data storage and handling per NIRSense's quality management requirements
• Directly manage, coach, and develop a team of mechanical engineers, including performance management, goal setting, and career development
• Drive team execution by setting priorities, allocating resources, and ensuring accountability for project timelines and deliverables

Minimum Qualifications:

• B.S. or M.S. in Mechanical or Biomedical Engineering or a related field
• 10+ years industry experience in design for wearable monitoring systems or medical devices
• Significant capability with Solidworks for designing rigid or flexible enclosures, molds, test fixtures, and optical interfaces
• Strong knowledge of safety, performance, and regulatory compliance requirements of medical devices, such as IEC 60601, ISO 10993, ISO 13485, ISO 14971, IEC 62366, and related FDA guidance
• Experience in scaling up prototypes to production
• Experience with rapid prototyping processes, including creating fixtures, molds, and prototype subassemblies with both 3D printing and injection molding systems
• Familiarity with Design for Manufacturing (DFM), Design for Assembly (DFA), and Design for Test (DFT) practices
• 3+ years of formal people management experience with direct reports in an engineering environment
• Demonstrated experience leading cross-functional engineering teams and delivering projects through full product development lifecycles
• Experience managing and/or mentoring junior through mid-career mechanical engineers and tactfully allocating engineering resources toward optimal results

Preferred Qualifications:

• Experience designing waterproof and corrosion-resistant products
• Design experience with systems interfacing with the human body
• Experience working with medical-grade, skin-contacting adhesives, silicones, and foams
• Experience with human factor / usability engineering
• Experience developing and iterating on industrial design concepts for manufactured systems
• Prior experience working with startups and with a local network
• Familiarity with military language and operational requirements