Job Description

The Manager, Engineering is responsible for leading a team of engineers in the sustaining and development of novel bioprosthetic venous valve devices and related accessories such as but not limited to delivery systems.  This position requires strong knowledge of 21 CFR 820.30, the design control process, study design, and statistical techniques.  The Manager is responsible for developing engineers and ensuring that design control deliverables are met.

Duties & Responsibilities

• Conceptualize, design and develop complex solutions for venous valves and related accessories such as but not limited to delivery systems
• Oversee the development of prototypes, pre-clinical evaluations, and safety/efficacy testing in accordance with ISO 5840 and other applicable standards and regulations
• Work collaboratively with Clinical, Manufacturing, Quality and Regulatory to ensure the design meets customer needs and is designed with consideration for Design-for-Manufacturing and Design-for-Quality
• Assist with clinical studies, including evaluation of Human Factors
• Develop risk documents (DFMEA, PFMEA, UFMEA, etc.)
• Develop test methods and procedures to evaluate prototype device performance
• Maintain compliance to internal and external requirements (21 CFR 820.30, 2017/745/EU)
• Apply technical knowledge and judgment to complex engineering problems
• Train clinicians on device use, as needed

Minimum Qualifications

• Bachelor’s degree in an Engineering discipline with 10+ years of medical device design engineering experience, with 3+ years in cardiac/vascular device development, OR
• Master’s degree in an Engineering discipline with 8+ years of medical device design engineering experience with 3+ years in cardiac/vascular device development, OR
• PhD in an Engineering discipline with 6+ years of medical device design engineering experience, with 3+ years in cardiac/vascular device development.
• Experience in team leadership
• Experience in tissue-based device (such as valve) design or transcatheter design
• Strong knowledge of statistical techniques and DOE
• Strong knowledge of ISO 5840 series
• Proficient in SolidWorks and CAD drawings
• Fluent in verbal and written English

Preferred Qualifications

• Bachelor’s in Biomedical Engineering or Mechanical Engineering, Master’s preferred
• Knowledge of extrusions, braiding, molding, bonding, tissue, metal properties (SS and NiTi)
• Knowledge of venous physiology and familiarity with clinical imaging modalities
• Experienced taking device from concept to market

Physical Job Requirements

• This position includes working in an office and operating room environment and may involve standing or sitting for several hours at a time. This job requires up to 30% travel.

Job Description

The R&D Engineer is a member of the Engineering department.  The role is involved in designing and developing prototypes of tissue based venous valves and related accessories including – but not limited to – delivery systems.  The R&D Engineer is responsible for leading design control projects and risk analyses related to development and performance/safety evaluation of valves and related accessories.

Duties & Responsibilities

• Build, design, and test innovative ideas and iterations for the NVNO’s portfolio of products (e.g., venous valves, delivery systems, etc.)
• Develop design control plans related to valves and related accessories in accordance with 21 CFR 820.30
• Identify performance testing required to ensure device safety/efficacy
• Work cross-functionally with Clinical Affairs and clinicians to ensure Human Factors Engineering is incorporated into device design
• Develop manufacturing Work Instructions related to valve and related accessories design
• Apply advanced mathematical and computational concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations and computational models to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis
• Identify vendors to develop custom components
• Perform dimensional inspection on critical components
• Work with Quality to ensure appropriate QC activities are identified to ensure device safety
• Own Engineering CAPAs, NCRs, Observations, as appropriate and assigned by management
• Create protocols and reports for studies performed in-house and externally (e.g., FEA, corrosion, AWT, etc.)
• Perform risk assessment (e.g., DFMEA, PFMEA, UFMEA, etc.)
• Mentor junior staff

Minimum Qualifications

• Experience in design and development of bioprosthetic valves and related accessories
• B.S. in Biomedical Engineering or similar: 5+ years’ industry experience
• M.S. in Biomedical Engineering or similar: 3+ years’ industry experience
• Ph.D in Biomedical Engineering or similar
• Strong understanding of the anatomy and functionality of the vascular and cardiac system
• Strong understanding of ISO 5840, ISO 14971, ISO 22442-1 and design controls requirements per 21 CFR 820.30, 2017/745/EU
• Experienced in risk analysis
• Excellent understanding of mathematical and computational modeling
• Proficient in SolidWorks and CAD drawings
• Organized and team-oriented
• Fluent in verbal and written English

Preferred Qualifications

• Strong understanding of properties of metals/electropolishing
• Strong understanding of properties of processed and unprocessed tissues

Physical Job Requirements

• This position includes working in an office and operating room environment and may involve standing or sitting for several hours at a time. This job requires up to 10% travel.

Job Description

The Regulatory Affairs Manager is a key member of the QA/RA team and reports to the VP of QA/RA. The position serves to assist with leading, development, and implementation of all Regulatory imperatives. This job is on-site and requires physical on-site presence.

Duties & Responsibilities

• Assist in developing and implementing domestic and international regulatory strategies supporting investigational use and commercialization of devices manufactured by enVVeno Medical, as indicated
• Promote collaborative, communicative working relationships with regulatory authorities and third-party regulatory service providers
• Assist in developing a facility-wide understanding of the key elements relating to regulatory compliance requirements
• Support all aspects of Risk Management
• Participate in development and maintenance of internal operating policies and procedures relative to Regulatory
• Assure conformity with domestic and international regulatory requirements

Minimum Qualifications

• Bachelor of Science/Engineering
• 10+ years of RA experience in the medical device industry
• Knowledge of 21 CFR 820, 2017/745 EU MDR, SOR 98-282, TG(MD)R Schedule 3, ANVISA 16 and ISO 13485
• Excellent communication skills

Preferred Qualifications

• 5+ years of experience with class III tissue based implantable products such as surgical and transcatheter bioprosthetic valves

Physical Job Requirements

• This job requires up to 10% travel.