Full-Time
Manufacturing Engineering Manager
Treace
201-500 employees
Designs and markets bunion correction systems
No salary listed
Ponte Vedra Beach, FL, USA
In Person
Travel of 10–30% is required for supplier visits and process troubleshooting.
Bachelor's
 Mechanical Engineering (1) |
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 Engineering Management (1) |
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- A bachelor’s degree in mechanical design or a closely related field is required.
- At least 8 years of relevant mechanical design and manufacturing engineering experience is required.
- Strong knowledge of design transfer processes and design for manufacturability is required.
- Experience working in a regulated environment involving FDA requirements, ISO 13485, ISO 14971 risk management, and ISO 10993 biological safety standards is required.
- Knowledge of Lean Manufacturing principles and Six Sigma methodologies is required.
- Experience with Microsoft Word, Excel, and Outlook is required.
- Willingness to travel 10–30% of the time for supplier visits and process troubleshooting is required.
- Manage the Technician team by guiding day-to-day work and operations in Manufacturing.
- Provide leadership support, coaching, and performance feedback to foster team culture and employee growth.
- Lead design transfer activities from Research and Development to manufacturing, ensuring a smooth handoff of product designs for production.
- Collaborate with Research and Development teams to optimize designs for manufacturability, efficiency, quality, and cost-effectiveness.
- Ensure compliance with biological safety requirements under ISO 10993 standards and regulations, including product safety evaluations and validation processes.
- Develop and implement manufacturing processes that meet quality and efficiency standards for medical devices.
- Provide technical leadership and guidance to cross-functional teams on manufacturing and process-improvement initiatives.
- Identify and resolve manufacturing issues while working hands-on with the production team to drive continuous improvement.
- Support development of Installation Qualification, Operational Qualification, and Performance Qualification validation protocols and ensure regulatory compliance.
- Collaborate with suppliers and external partners to ensure the quality and reliability of manufacturing components and materials.
- Stay current with industry trends, technologies, and regulations related to medical device manufacturing.
- Help identify new suppliers for the compliant manufacture of components and finished goods with assistance from Supply Chain, Product Development, and Quality.
- Provide subject-matter-expert guidance and mentorship to business functions as needed.
Treace Medical Concepts designs, manufactures, and markets orthopedic surgical systems for foot and ankle care, focusing on bunion correction and midfoot deformities. Its flagship Lapiplasty 3D Bunion Correction System uses patented instruments, implants, and a multi-plane approach with Biplanar plating to correct bunions at the root and enable faster weight-bearing. The company also offers Adductoplasty for coexisting midfoot deformities, Hammertoe PEEK Fixation, and SpeedPlate bone-fusion systems, selling kits through a direct sales force and distributors to physicians, ambulatory surgery centers, and hospitals. Treace aims to grow its portfolio and market leadership in foot-and-ankle devices by expanding adoption and improving surgical outcomes.
Company Size
201-500
Company Stage
IPO
Headquarters
Ponte Vedra Beach, Florida
Founded
2014
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Simplify's Take
What believers are saying
- Q2 2026 case volume grew high single digits, signaling surgeon adoption acceleration.
- Management raised 2026 revenue guidance to $204 million-$212 million after August 7 results.
- SuperBite and HyperPlate XM entered commercialization, targeting a $300 million addressable-market expansion.
What critics are saying
- Q2 2026 revenue fell 4% to $45.4 million; lower-priced mix persists through Q3.
- Treace faces Zimmer Biomet litigation and PTAB challenges from Paragon 28 through 2026.
- Cash was $45.6 million on June 30, 2026; prolonged losses threaten financing flexibility.
What makes Treace unique
- Lapiplasty patented 3D bunion correction remains Treace’s core, with 80 U.S. patents.
- Direct sales reaches 3,300-plus surgeons, locking in procedure adoption and workflow.
- SuperBite, HyperPlate XM, and Lightning expand Treace beyond bunions into fusions.
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Benefits
Parental Leave
401(k) Company Match
Company Equity
Unlimited Paid Time Off
Growth & Insights and Company News
6 month growth
↑ 0%1 year growth
↑ 1%2 year growth
↑ 0%Treace Medical Concepts reported Q2 2026 revenue of $45.4 million, down 4% year-over-year, driven by lower distributor sales and a shift to lower-priced products. Gross margin declined to 78.5% from 79.7% in the prior year period. Despite the revenue decline, the company narrowed its net loss to $15.9 million, or $0.24 per share, compared to $17.4 million a year earlier. Operating expenses fell 8% to $50.6 million. Cash usage dropped 57% year-to-date. Case volume growth accelerated to high single digits as 40% of Lapiplasty surgeons adopted at least one of three new bunion systems. The company raised full-year revenue guidance to $204 million to $212 million, representing a decline of 0% to 4% versus 2025. Cash and marketable securities totalled $45.6 million as of 30 June 2026.
Treace Medical Concepts has completed the first surgical case using its HyperPlate XM Dynamic Compression Locking Implant System. The device combines FastPitch locking screws with titanium compression implants to deliver rapid insertion and dynamic compression for midfoot and hindfoot procedures. Dr Paul Dayton of the Foot & Ankle Center of Iowa performed the inaugural procedure, a talonavicular joint fusion. He praised the implant's anatomic fit and stability, noting that the accompanying GreatReleaseXM Rapid Release Instrument improved surgical efficiency. The system features an ultra-low profile design for procedures including talonavicular, calcaneocuboid, naviculocuneiform and tarsometatarsal fusions, plus Evans calcaneal osteotomies. Full commercialisation is expected in the third quarter of 2026, expanding Treace's bunion and midfoot portfolio into a larger addressable market.
Treace to present at the Sidoti Small Cap Conference. PONTE VEDRA, Fla., June 11, 2026 (GLOBE NEWSWIRE) - Treace Medical Concepts, Inc. ("Treace" or the "Company") (NasdaqGS: TMCI), a medical technology company driving a fundamental shift in the surgical treatment of bunions and related midfoot deformities, today announced it will present at the Sidoti Small Cap Conference, Thursday, June 18, 2026, beginning at approximately 1:45 pm ET. A live webcast and replay of the presentation will be available on the Company's investors relations website at https://investors.treace.com/. Internet Posting of Information Treace routinely posts information that may be important to investors in the "Investor Relations" section of its website at www.treace.com. The Company encourages investors and potential investors to consult the Treace website regularly for important information about Treace. About Treace Medical Concepts Treace Medical Concepts, Inc. is a medical technology company with the goal of advancing the standard of care for the surgical management of bunion and related midfoot deformities. Bunions are complex 3-dimensional deformities that originate from an unstable joint in the middle of the foot and affect approximately 67 million Americans, of which Treace estimates 1.1 million are annual surgical candidates. Treace has pioneered and patented the Lapiplasty(R) 3D Bunion Correction(R) System - a combination of instruments, implants, and surgical methods designed to surgically correct all three planes of the bunion deformity and secure the unstable joint, addressing the root cause of the bunion and helping patients get back to their active lifestyles. To further support the needs of surgeons and bunion patients, Treace offers its Adductoplasty(R) Midfoot Correction System, designed for reproducible surgical correction of midfoot deformities, two systems for minimally invasive osteotomy procedures, namely the Nanoplasty(R) 3D Minimally Invasive Bunion Correction System and the Percuplasty(TM) Percutaneous 3D Bunion Correction System, and the SpeedMTP(R) MTP Fusion System. Treace continues to expand its footprint in the marketplace by extending its SpeedPlate(R) rapid compression implant platform to new applications, as well as providing surgeons with advanced digital solutions with its IntelliGuide(R) patient specific, pre-op planning and cut guide technology. For more information, please visit www.treace.com. Contacts: Treace Medical Concepts Mark L. Hair Chief Financial Officer [email protected] (904) 373-5940 Investors: Gilmartin Group Philip Trip Taylor [email protected] Company Profile Treace Medical Concepts, Inc. Industry: Medical Equipment Website: https://treace.com Recommended reading.
Treace Medical Concepts reported first-quarter revenue of $47.2 million, down 10% year-over-year, as a shift towards lower-priced minimally invasive products pressured results. The company reaffirmed its full-year 2026 revenue guidance of $202 million to $212 million, representing a decline of 5% to flat compared with 2025. Chief Executive Officer John Treace said the company has evolved beyond its Lapiplasty foundation into a comprehensive bunion solutions company, citing new procedure innovations including Nanoplasty, Percuplasty 3D MIS and SpeedMTP systems launched in 2025. The company posted a net loss of $18 million, or $0.28 per share, compared with a loss of $15.9 million a year earlier. Treace expects revenue declines to continue until the fourth quarter, its seasonally strongest period.
Treace Medical Concepts has seen its fair value estimate raised to $4.25 from $3.85, though analyst price targets remain divided between roughly $2 and $7, reflecting uncertainty over growth and product mix. Lake Street maintained a Buy rating with a $7 target, viewing fourth-quarter results as slightly favourable and 2026 guidance as mixed rather than negative. However, Truist cut its target to $2 from $3, citing pressure from newer products carrying lower average selling prices than the Lapiplasty system. The company issued 2026 revenue guidance of $200 million to $212 million, representing a 6% decline to flat growth. New products including the SuperBite Compression Screw System and SpeedXM Midfoot Fusion System are expected to expand its addressable market by $300 million.