Principal Research & Development (R&D) Engineer

Posted 3 Days Ago
Hiring Remotely in Ponte Vedra, FL, USA
Remote
Senior level
Healthtech • Manufacturing
Treace Medical Concepts is focused on advancing the standard of care for Hallux Valgus (bunion) surgery.
The Role
Lead and execute product design projects, mentor engineers, ensure manufacturability, and oversee compliance in medical device development.
Summary Generated by Built In
Company Description

Treace’s mission is to be the leader in the surgical treatment of bunions by establishing the Lapiplasty® System as the standard of care. We are committed to operating our business with the highest standards of ethical conduct. We intend to exceed our customers’ expectations through an innovation-driven, high-velocity approach to solving treatment and surgical problems. With our products and services, our mission is to assist foot and ankle surgeons in improving patient outcomes and reducing healthcare costs, while providing rewarding experiences and opportunities for our employees and stakeholders.

Job Description

Are you a technical expert and innovative leader looking to make a significant impact in product design and development? We are seeking a Principal R&D Engineer to manage and execute key design projects while mentoring other engineers. This role offers the opportunity to lead major product development initiatives from concept to production and contribute to the company’s short-term and long-term goals.

Primary Duties & Responsibilities

As a Principal R&D Engineer, your responsibilities include:

  • Leading, participating in, and supporting activities throughout product development, including:
    • Concept generation
    • Project planning, design, and execution stages
    • Prototyping, design for manufacturability (DFM), design for inspection (DFI)
    • Risk assessments, pilot production, and design reviews
    • Verification, validation, and testing (protocol authorship, physical testing, reports)
    • Pre-production and full production launch
  • Demonstrating expertise in material selection, manufacturing methods, inspection techniques, and critical measurements.
  • Engaging directly with customers alongside sales and marketing to gather design ideas, document concepts, and transition them into high-quality production-ready products.
  • Ensuring compliance with the company’s design quality system.

We're looking for candidates with the following qualifications:

Design Expertise - Expert CAD knowledge (preferably SolidWorks) for creating parametric models and ASME Y14.5-compliant prints.

Manufacturing Feasibility - Proficient in interacting with design and manufacturing teams to balance manufacturability, reliability, and cost-effectiveness.

Analytical and Technical Expertise - Advanced knowledge of CAD design, 3D print generation, FEA simulations, and ISO standards.

Communication and Leadership - Strong ability to communicate schedules, budgets, designs, and testing results effectively to teams and stakeholders.

Customer-Centric Approach - Ability to generate product designs based on customer input and surgeon feedback.

Hands-On Approach - Comfort with cadaver work, surgical settings, and detailed research experiments to test feasibility.

Collaborative Team Player - Proven ability to work on cross-functional teams and assist in creating design documentation for medical devices.

To excel in this role, you should demonstrate:

  • Exceptional organizational and communication skills.
  • Strong attention to detail.
  • Expertise in product development, material selection, and industry best practices.
  • A desire to work on complex engineering problems and mentor your peers to grow the team’s capabilities.

Educational and Software Proficiency

  • Advanced experience using Microsoft Office tools (Word, Excel, PowerPoint, Project).
  • SolidWorks proficiency required; familiarity with FEA and GD&T is a must.

Qualifications

  • Bachelor’s degree in Mechanical Engineering or equivalent engineering discipline
  • 7+ years’ mechanical design and manufacturing experience of which 5+ years of actual product development experience bringing innovative product to market from conception to launch in  regulated industry. (Preference is given to medical device development).

Additional Information

All your information will be kept confidential according to EEO guidelines.

Treace's Privacy Policy

It is Treace’s policy not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, veteran status or any other characteristic protected by applicable law. EEO/Disabled/Veterans Employer
 

Treace is a drug free employer.

Skills Required

  • Bachelor's degree in Mechanical Engineering or equivalent engineering discipline
  • 7+ years' mechanical design and manufacturing experience
  • 5+ years of actual product development experience in regulated industry
  • Expert CAD knowledge (preferably SolidWorks)
  • Advanced knowledge of CAD design, FEA simulations, and ISO standards
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The Company
HQ: Ponte Vedra, FL
495 Employees
Year Founded: 2014

What We Do

Treace Medical Concepts, Inc. is a medical technology company with the goal of advancing the standard of care for the surgical management of bunion deformities and related midfoot correction. Bunions are complex 3-dimensional deformities that originate from an unstable joint in the middle of the foot and affect approximately 67 million Americans1, of which Treace estimates 1.1 million are annual surgical candidates. Treace Medical has pioneered and patented the Lapiplasty® 3D Bunion Correction® system – a combination of instruments, implants, and surgical methods designed to surgically correct all 3 planes of the bunion deformity and secure the unstable joint, addressing the root cause2,3 of the bunion. At Treace Medical Concepts, Inc., our mission is to advance the standard of care for the surgical management of bunions and related midfoot deformities. Treace Medical offers the Adductoplasty® System, the Hammertoe PEEK Fixation System, the SpeedPlate™ System, and other ancillary The content herein is for informational purposes and intended for healthcare professionals only. Treace Medical Concepts, Inc. does not dispense medical advice. A surgeon should rely on his or her own professional clinical judgment when deciding whether to use a specific product when treating a particular patient. Prior to use of the device, the surgeon should refer to the instructions for use for complete indications, contraindications, warnings, and risks. Complete risk and benefit information: www.treace.com. Visit www.treace.com/privacy-policy for our Privacy Policy. Treace Medical will make an offer of employment only to individuals who have applied for a position using our official application. Be on alert for possible fraudulent offers of employment. Treace Medical will not solicit money or banking information from applicants.

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