Director of Product Development jobs in United States
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SINTX (NASDAQ: SINT) · 14 hours ago

Director of Product Development

SINTX is a company focused on innovative medical device development, and they are seeking a Director of Product Development to manage the development pipeline and oversee design and development projects. The role involves leading product development from ideation to commercialization, ensuring timely production launches, and supporting regulatory submissions.

BiotechnologyHealth CareMedical Device

Responsibilities

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

Qualification

FDA design processCAD softwareMedical device developmentMechanical designAdditive manufacturingMicrosoft OfficeCommunicationInterpersonal skills

Required

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
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

Preferred

Experience in Foot & Ankle, Extremities, or Spine a plus
Experience with additive manufacturing, a plus
Experience with sterile packaging development, a plus

Benefits

401(k)
Medical, Dental, Vision insurance
Life insurance
Disability insurance
AD&D insurance
Paid time off
Holidays

Company

SINTX (NASDAQ: SINT)

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SINTX is an OEM ceramics company that develops and commercializes advanced ceramics for medical applications.

Funding

Current Stage
Public Company
Total Funding
$207.88M
Key Investors
National Institutes of HealthCrede CapitalGroupHercules Capital
2025-09-08Post Ipo Equity· $3.8M
2025-02-26Post Ipo Equity· $5M
2024-04-03Post Ipo Equity· $1.5M

Leadership Team

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B. Sonny Bal
Chairman of the Board
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Bryan J. McEntire
Chief Scientific Officer
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Company data provided by crunchbase