About the Company:

Bionica Labs is a medical technology company focused on creating world-leading wearable sensor systems to measure cerebral and somatic oxygenation. We’re a small, dedicated team seeking candidates interested in thoroughly understanding problems, excited about designing devices with broad applicability, and ready to follow where the prototype process leads us. We’re searching for a fellow enthusiast to play an integral role in expanding our engineering team and capabilities.

Job Summary:

We are seeking an experienced manufacturing engineer to fulfill a broad set of objectives related to our wearable sensor systems. This person will help expand our manufacturing capabilities, component sourcing, and production readiness to help transition our prototypes into commercial scale products.

Job Responsibilities:

• Work with Bionica Labs engineers to translate prototype recipes and practices to external manufacturers, component suppliers, and engineering vendors via comprehensive design output documentation

• Lead risk assessment activities to identify product quality, process, and compliance risks and aid engineering efforts to countermeasure or mitigate those risks

• Vet system designs for large scale manufacturability and countermeasure identified problems

• Lead root cause analysis (RCA) of production failures and field-identified issues and reflect these via formal system updates to manufacturers and regulatory bodies as appropriate

• Support test fixture specification and development for contract manufacturer validation of Bionica Labs products

• Conduct vendor site visits to confirm compliance to ISO 13485 standards

• Support Bionica Labs quality management system (QMS) documentation and related regulatory requirements

• Follow best practices for vendor selection to ensure compatibility with medical device standards, including review of available compliance documentation

• Report to the Director of Engineering

Minimum Qualifications:

• B.S. in Manufacturing, Biomedical, Mechanical, or Industrial Engineering, or a related field

• Three (3) or more years experience working on commercial products subject to FDA market regulation

• Experience with transition from early prototypes to scale manufacturing, including volume sourcing and supply chain management

• Experience working with ISO 13485 contract manufacturers to transition prototype designs to manufacturer’s production lines and verifying compliance with medical device standards

• Experience supporting medical device safety standards including IEC 60601-1 and 60601-1-2 and risk analysis documentation including ISO 14971

• Experience with Design for Manufacturing (DFM), Design for Assembly (DFA), and Design for Test (DFT) processes

Preferred Qualifications:

• Master’s degree plus industry experience in wearable human monitoring systems or medical devices

• Familiarity with software tools used for wearable system design, such as Solidworks, AutoCAD, Altium, Fusion 360, or others

• Experience vetting, selecting, and validating biocompatible materials with suppliers and engineers

• Background in health care, military, biomedical, wearable, or wellness products

• Prior experience working with startups and with a local network

Salary: Compensation package will be commensurate with the successful applicant’s experience. Anticipated hiring range is $90,000-120,000.

Hours: Full time

Travel: 0-10%

Interested applicants please forward 1) Cover Letter, 2) Resume/CV, and 3) Three professional references to Careers @BionicaLabs.com.

Job Type: Full-time

Pay: $90,000.00 - $120,000.00 per year

Benefits:

• Paid time off

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Cary, NC 27518: Reliably commute or willing to relocate with an employer-provided relocation package (Required)

Experience:

• supporting medical device safety standards: 1 year (Preferred)
• w/ commercial products subject to FDA regs: 3 years (Required)
• transition from early prototypes to scale manufacturing: 3 years (Preferred)
• working with ISO 13485: 2 years (Required)

Work Location: One location

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