Naväge is experiencing rapid growth and is actively looking for talented individuals to help us achieve our next phase of success. If you're passionate about making an impact, and eager to grow with us, please apply!
SUMMARY
Establish plans for and manage new product development in compliance with applicable regulations and industry practices, with an emphasis on Over-the-Counter (OTC) Medical Devices. Specifically, this position shall perform the following:
Establish and lead the Project Team (internal / external)
Establish and hold the Project Team to its schedule and budget
Be the Technical Expert with outside agencies
Partner with Marketing and Sales to ensure the Product Design best fits Consumer Needs
Provide claim support (i.e., evidence, literature, test design)
Drive new products through to commercialization and scale-up
“Graduate” new products over to ongoing Operational Management
With the CEO, establish Product Pipelines for 1, 3, 5, and 10-years to achieve Business Objectives.
Oversee, prioritize, and manage support personnel (i.e., internal FTE and/or external contractors, suppliers) to achieve company Objectives:
Technical Staff, e.g., Engineering, Statistical
Regulatory and Quality Personnel
Provide technical expertise and assist with the preparation of technical documentation to fulfill Regulatory and Quality objectives (i.e., new product regulatory submissions, ISO 13485:2016 audits).
Lead Patent Management at RSI, including new patent applications, patent maintenance, licensing, freedom-to-operate assessments, and patent strategies with its legal firms and design partners.
Provide process and system-level expertise to improve efficiencies while maintaining compliance to applicable Regulations and Standards, including as example electronic Quality Management Systems (eQMS), Design Control and Product Development streamlining, and New Product “due diligence” processes.
Provide technical support for RSI clinical investigational and/or usability studies, including device prototyping, risk-based product development approach, and study design and/or ethic committee submission support.
ESSENTIAL DUTIES & RESPONSIBILITIES
Provide input to the CEO and Executive Management Team on RSI’s mission and vision. Assist the CEO by translating RSI’s corporate objectives into strategic and tactical Technical Operating Plans to ensure successful new product development and commercialization, customer satisfaction and financially sound business growth.
Prepare Product Development Plans for New Products, including resource identification (internal vs. external sourcing), Gantt charts/schedules, budgeting, milestones, and program risk mitigation strategies.
Provide testing strategies and/or technical evidence to substantiate desired Marketing Claims for new products.
Identify suppliers (i.e., contract engineering firms and/or contract manufacturing firms) to augment RSI’s internal capabilities, to ensure new product development success. Assist Quality with the technical qualification of these suppliers.
Prepare technical documentation for domestic and international medical device regulatory submissions and Quality System certifications, e.g., ISO 13485:2016 to ensure compliance and completeness. Examples: Product Requirement Specification and Traceability Matrix, Risk Management Files, Verification and Validation Testing, Consensus Standard Safety Testing (Biocompatibility, Electrical Safety, EMC).
Manage internal and external Engineers, Regulatory and Quality staff, suppliers, and other Service Providers (i.e., patent attorneys, human factors) to achieve corporate objectives related to product development.
Provide technical expertise and support for Operations, as needed, related to priority Quality System activities for existing Naväge products (i.e., FDA 483 observations).
Support Regulatory and Quality with technical expertise for third party audits (FDA, Notified Body) of Design History File (DHF) and/or Technical File documentation.
With support of the Team, identify areas of additional growth interest and establish professional development plans for expanded responsibilities, as applicable.
Maintain current with competitive products, applicable testing and regulatory standards, guidance documents, and industry working groups.
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty effectively. The qualifications and experience listed below are representative of the knowledge, skill and/or ability required.
Leadership roles involving technical personnel
Results-focused with demonstrated track record (i.e., direct involvement in the development and successful commercialization of multiple medical devices)
Experience in managing multiple, medium size programs or projects
Experience in identifying, developing, and critiquing Intellectual Property (IP)
Experience in budgeting, program planning, technical organization building, mentoring, and grooming
Strong communication and organizational skills
Experience in consumer products and consumer-centric design.
Minimum of fifteen (15) years in product development management or senior operational role at medical device company, with OTC experience desirable.
Significant working knowledge of medical device regulatory requirements (FDA, ISO).
Attributes for this position:
Player-coach [ability to think strategically while simultaneously being able to do first-person work]
Entrepreneurial attitude
High sense of ownership of business results
High degree of accountability
Ability to manage and optimize R&D funds
Ability to create and run a high-functioning team as company grows
Personality and drive needed to operate in Private Equity
Education
Bachelor’s degree in engineering or related-product development area; advanced degree desirable.
Language Skills
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, and government regulations. Strong written and verbal communication skills. Ability to effectively present information and respond to questions from groups of managers, customers, suppliers, and the general public.
Mathematical Skills
Ability to apply basic mathematical tools and basic statistical analysis.
Reasoning Abilities
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Certificates, Licenses, Registrations
Certified professional engineer desirable.
Physical Demands
No special demands.
Travel Demands
Minor to moderate level of out-of-state travel anticipated (no more than 20%).
Employment type
Full-time
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