The Director of Product Development is responsible for the timely execution and management of the development pipeline as well as oversees all design and development projects to meet the Company’s short term and long-term goals. This individual will utilize their skills to develop the team and provide oversight to ensure timely production launch and product maintenance. They will support regulatory submissions and will be the lead member of the development process, responsible for overseeing all project related activities. The ideal individual will also possess a strong knowledge of the FDA design and development process and have extensive CAD knowledge and skills for the oversight of models and manufacturing drawings. 

· Manage product development team, providing guidance and expertise on design history file creation, product design and clinician interaction

· Lead the product development process

· Oversee product development from ideation to commercialization through entire product life cycle and provide guidance to engineering staff

· Responsible for interpreting raw feedback/ideas into valuable input and appropriately weighing such input against competing factors to ensure that development projects progress toward success 

· Project manages all development related activities

· Oversee conceptualizing new design ideas

· Serve as the primary point of contact for clinical development teams

· Responsible for accurately understanding mechanical design and manufacturing problems and supporting the team in exploring a variety of potential solutions 

· Create and Manage Design Control Documentation for design history files 

· Lead, participate in, and support the following product development activities:

            Concept, planning, design and execution stages of major new products or product enhancements

            Risk assessment, Prototyping, Design for Mfg. and Design for Inspection

            Testing (Protocol authorship, Physical Testing, and Test Report generation)

            Pilot Production

            Design reviews

            Verification, Validation, Pre-production

            Production support

· Oversee and coordinate interaction with suppliers, contractors, testing houses, etc. 

· Assist in the development or required documentation for regulatory submissions

· Observe surgery (live, cadaver, or video) for assigned devices in surgical situations. Document all notes. 

· Responsible for overseeing the protection of intellectual property (utility patents, design patents, trade secrets) 

· Coordinate with internal quality and manufacturing teams 

· Provide guidance and support the development of in-house manufacturing capabilities for additive manufacturing of implants and disposable instruments

· Other duties as directed by manager.

Qualifications

· Bachelor’s Degree in Biomedical or Mechanical engineering or related engineering field.

· 10+ years’ experience in a medical device development environment

· Previous development of medical devices in orthopedics. Experience in Foot & Ankle, Extremities, or Spine a plus.

· Ability to self-manage, prioritize initiatives, and take ownership in resolving issues with urgency and vigor.

· Ability to utilize CAD software such as Solidworks

· Ability to read and interpret technical drawings and schematics for parts.

· Proficient in Microsoft Office

· Excellent communication and interpersonal interaction skills to effectively interface internally, with customers and vendors

· Experience with additive manufacturing, a plus

· Experience with sterile packaging development, a plus

Travel

· Occasional travel, expected to be around 10%, but may fluctuate based on development cycle (i.e. early concept vs production)

Environmental Factors and Physical Requirements

The position is generally sedentary in an office environment but will require frequent trips to the manufacturing floor. While performing duties of this job, an employee may be required to perform any of the following: standing, walking and working with and around equipment or tools frequently. Lifting and moving products and parts. These duties can be performed with, or without, reasonable accommodation. Additionally, this job requires certain mental demands, including the ability to use judgment, withstand moderate amounts of stress and maintain attention to detail with, or without, reasonable accommodation. 

Benefits:

· 401(k) 

· Medical, Dental, Vision insurance 

· Life insurance 

· Disability insurance 

· AD&D insurance 

· Paid time off

· Holidays