Position Summary

Seeking an experienced engineer to lead the design, development, and customization of spinal implant instruments. Ideal candidates have expertise in spinal instrumentation, direct collaboration experience with U.S. spine surgeons, and a background in major spinal implant companies. This role involves full product lifecycle development, regulatory compliance, cross-functional teamwork, and close integration with implant design teams.

Key Responsibilities

 Lead product development from concept to commercialization, ensuring compliance with FDA and ISO design control standards.

 Design full instrument systems supporting lumbar (TLIF/PLIF/LLIF/ALIF) and cervical (ACDF) interbody fusion cages, including trials, inserters, distractors, reduction tools, and MIS-compatible workflows.

 Collaborate closely with U.S. spine surgeons and KOLs to collect clinical feedback and customize instruments based on surgical workflow needs.

 Participate in cadaver labs and OR observations to refine usability, ergonomics, workflow, and surgeon handling of instruments.

 Work closely with implant design teams to ensure seamless instrument–implant interface and system-level performance.

 Perform CAD design and modeling, integrating biomechanics and DFM principles.

 Manage project timelines, risks, and cross-functional communication across engineering, quality, regulatory, and manufacturing teams.

 Conduct testing, FEA, mechanical evaluation, and usability assessments as needed for verification and validation.

 Develop and maintain design documentation including DHF, specifications, technical drawings, and risk management files.

 Support regulatory submissions (e.g., 510(k)) and address post-market engineering issues.

Required Qualifications

 Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field.

 5–7+ years of medical device development experience, with strong focus on spinal or orthopedic surgical instruments.

 Direct experience collaborating with U.S. spine surgeons on custom instruments and system optimization.

 Proficiency in CAD tools, GD&T, and tolerance stack analysis.

 Knowledge of instrument materials, metals, coatings, finishing processes, and sterilization/cleaning standards.

 Strong understanding of design controls, usability engineering, risk management, and 510(k) regulatory pathways.

 Excellent problem-solving, project management, and communication skills. Preferred Qualifications

 Experience working with major spinal companies (e.g., Medtronic, Stryker, Zimmer Biomet, Globus).

 Successful track record developing spinal instrument systems integrated with interbody implants.

Job Overview

This role focuses on commercializing advanced 3D-printed spinal interbody fusion cages—including lumbar (TLIF/PLIF) and cervical ACDF cages—in the U.S. market. Ideal candidates have strong prior spine sales experience and established surgeon or distributor relationships. You will educate spine surgeons on the clinical value of stiffness-matching lattice implants, support ACDF and lumbar fusion procedures, and drive adoption through high-autonomy sales execution. This role offers significant commission upside for high performers in an early-stage growth environment.

Core Responsibilities

 Execute U.S. regional sales plans for lumbar and cervical (ACDF) 3D-printed interbody fusion cages, achieving revenue and surgeon adoption targets.

 Develop deep relationships with spine surgeons, providing in-OR case support for both ACDF and lumbar fusion procedures.

 Expand and manage local distributor networks; provide product training and sales enablement related to ACDF and lumbar cage systems.

 Identify, target, and convert key accounts across hospitals, ASCs, IDNs, and other spine care facilities.

 Communicate product advantages—including stiffness matching, porosity-driven bone ingrowth, and 3D-printed structural performance—based on surgeon needs and clinical scenarios.

 Participate in regional and national academic conferences, cadaver labs, and clinical training events to increase product visibility.

 Track regional competitive dynamics (PEEK, titanium, 3D-printed offerings) and provide structured insights to the commercial team.

 Coordinate order fulfillment, contracting, and after-sales service to ensure high levels of customer satisfaction.

 Prepare sales reports, forecasts, and account plans on time.

Qualifications

 Bachelor’s degree preferred; life sciences, biomedical engineering, or related disciplines a plus.

 Minimum 2–3 years of spine implant sales experience (required).

 Experience selling ACDF cervical cages, cervical plating, or other anterior cervical systems strongly preferred.

 Experience selling lumbar cages (TLIF/PLIF/LLIF/ALIF) also preferred.

 Existing relationships with U.S. spine surgeons or local spine distributors is a major advantage.

 Comfortable providing OR support for ACDF and lumbar fusion and educating surgeons on implant selection.

 Strong hunter mentality—proactively opens new accounts, drives evaluations, and pushes conversions.

 Able to operate autonomously in a startup environment with minimal supervision.

 Strong communication, technical learning ability, and customer engagement skills.

 Knowledge of FDA regulations and experience with 3D-printed devices is a plus but not required.

Position Summary

We are seeking a hands-on Product Engineer to support the development of innovative spinal implant systems, including 3D printed interbody fusion cages, pedicle screw systems, anterior cervical plates, and MIS (Minimally Invasive Surgery) interbody fusion devices and associated surgical instruments. The ideal candidate will work closely with clinical partners to identify usability and performance improvements, translate feedback into actionable design inputs, and coordinate with internal and external teams to drive product refinement.

Key Responsibilities

 Collect and organize surgeon feedback during lab evaluations and clinical use of spinal implant systems, including: 3D printed interbody fusion cages; Pedicle screw systems; Anterior cervical plate systems; MIS interbody fusion devices; Associated surgical instruments and instrument trays.

 Identify improvement opportunities in implant and instrument design, usability, ergonomics, and workflow.

 Translate clinical feedback into clear engineering requirements and communicate with design and R&D teams.

 Work with surgeons, engineers, and manufacturing partners to evaluate prototype and production tools.

 Track design changes, maintain feedback logs, and support design verification and validation testing.

 Assist in the development of training materials and surgical technique guides.

 Support regulatory documentation and risk analysis related to design modifications.

Participate in cross-functional meetings to ensure surgeon feedback is incorporated effectively into the product lifecycle.

Required Qualifications

 Bachelor’s degree in Mechanical, Biomedical, or related Engineering field.

 3+ years of experience in medical device development, preferably spinal or orthopedic implants/instruments.

 Familiarity with surgical workflow and operating room environment.

 Strong communication skills for interacting with surgeons and cross-functional teams.

 Basic proficiency in CAD (SolidWorks, or equivalent) and design documentation.

 Understanding of design controls, usability engineering, and risk management processes. 

Preferred Qualifications

 Experience with one or more of the following: Interbody fusion devices; Pedicle screw systems; Cervical plating systems; MIS spinal systems.

 Prior involvement in surgeon evaluation sessions or cadaver labs.

 Knowledge of additive manufacturing (3D printing) technologies for medical implants.

 Experience in FDA Class II device development under ISO 13485/QSR environment.

Location: Boston (travels as needed)

Job Summary

ZSFab Inc. is seeking an experienced Senior Quality & Regulatory Engineer to serve as the sole U.S.-based quality and regulatory representative for our spine medical device operations. This role is critical as we hold FDA 510(k) clearances as the U.S. Legal Manufacturer while all design, development, and manufacturing activities are conducted by our affiliated facilities in China.

The ideal candidate will establish and maintain robust oversight of our Chinese OEM partners' quality systems, ensure full compliance with FDA regulations for imported medical devices, and serve as the primary liaison with FDA. This is a hands-on, autonomous role requiring deep expertise in FDA 21 CFR Part 820(QMSR), ISO 13485, and cross-border supply chain quality management.

Key Responsibilities

1.Quality Management System (QMS):

 Support the development, implementation, and maintenance of the Quality Management System in compliance with ISO 13485, FDA 21 CFR Part 820, and other relevant regulations and standards.

 Establish and maintain Quality Agreements with all critical suppliers (domestic and international), defining regulatory responsibilities, change control protocols, and data access rights per FDA 21 CFR Part 820.50 and ISO 13485.

 Lead all FDA-related communications as the official U.S. contact: respond to 483 observations, Warning Letters, Import Alerts, and information requests; coordinate FDA inspections of foreign facilities when applicable.

 Establish and maintain post-market surveillance systems: complaint handling, adverse event reporting, and trend analysis for all distributed products.

 Assist in conducting internal audits to ensure adherence to QMS requirements and drive continuous improvement.

 Lead in the certification process and maintenance for ISO 13485, MSSAP, etc.

 Support the regulatory approval process in various countries for exporting.

2.Product Development:

 Collaborate with R&D and manufacturing partners during design transfer phases; review and approve design history files (DHF), device master records (DMR), and device history records (DHR).

 Participate in design reviews and risk assessments; evaluate design changes initiated by any manufacturing facility for impact on FDA 510(k) clearances and determine regulatory submission requirements (Special 510(k), Traditional 510(k), or letter-to-file).  

3.Process Improvement:

 Identify and drive process improvements at manufacturing facilities based on data analysis, audit findings, and FDA feedback; require and verify corrective actions.

 Develop and maintain ZSFab's oversight procedures, including work instructions for reviewing supplier documentation, SOPs for import compliance, and supplier audit plans.

4.Inspection and Testing- Supplier Review & Final Release:

 Perform final review of batch records, test data, and certificates of analysis prior to U.S. market release; utilize statistical tools to analyze trends and drive decision-making.

 Establish incoming inspection protocols for U.S.-based receiving activities (e.g., label verification, documentation completeness checks, dimensional inspections).

5.Non-Conformance and CAPA:

 Investigate and resolve non-conformances, perform root cause analysis, and implement corrective and preventive actions (CAPA).

 Track and report on the effectiveness of CAPA activities.

6.Supplier Quality:

 Qualify and manage all critical suppliers (domestic and international): conduct audits, monitor performance metrics (quality, delivery, regulatory compliance), and manage supplier scorecards.

 Work with suppliers to resolve quality issues; ensure compliance with specifications, standards, and U.S. regulatory requirements.

7.Regulatory Compliance- Import, Labeling & Market Access:

 Ensure import compliance per 21 CFR Part 807 Subpart E: maintain Establishment Registration and Device Listing, manage FDA entry review and detention issues, coordinate with U.S. Customs brokers.

 Oversee Unique Device Identification (UDI) compliance: ensure all devices bear compliant labels; manage GUDID database submissions.

 Manage labeling control: review and approve product labels, instructions for use (IFU), and patient implant cards per 21 CFR Part 801; assess labeling changes for 510(k) impact.

 Ensure all products and documentation comply with applicable FDA requirements for imported medical devices; support regulatory submissions as needed.

 Maintain Importer of Record compliance; ensure accurate product codes, manufacturer identification, and FDA Affirmations of Compliance.

8.Training and Development:

​​​​​​​ Provide training to employees on quality standards, procedures etc.

 Stay current with industry trends and advancements in quality engineering and medical device regulations.

​​​​​​​Qualifications:

​​​​​​​ 1-2 years of experience as a Quality System Engineer for implantable medical device products .

 Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and other relevant medical device regulations.particularly Subpart E (Purchasing Controls), Subpart G (Production and Process Controls), and import requirements for foreign manufacturers.

 Proven experience with FDA inspections: QSIT inspection preparation, 483 response, and Warning Letter remediation; experience with foreign facility inspections preferred.

 Strong expertise in ISO 13485:2016, ISO 14971 (Risk Management), and MDSAP requirements; experience hosting Notified Body audits.

 Experience with statistical analysis, root cause analysis, and risk management.

 Proficiency in quality tools and methodologies.

 Excellent problem-solving, communication, and interpersonal skills.

 Detail-oriented with a strong commitment to quality and continuous improvement.

 Certified Quality Engineer (CQE) or other relevant certification is a plus.

 Availability to work on a contract basis for the specified duration.

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​​​​​​​Company: ZSFab Inc (https://www.zsfab.com/)

Address: 96 Clematis Ave, STE 2F, Waltham, MA 02453

Company introduction

ZSFab is a well-funded company located in Greater Boston, MA. We are a team with expertise in 3D-printing, materials and medical devices from Harvard, USC, Tsinghua, and Peking University. We have sister companies located in Jiaxing and Beijing, China.  

ZSFab is dedicated to producing high performance, patient-matched as well as customized medical implants,surgical guides and other additively manufactured end-use products. We are developing unique solutions that integrate our software tools, advanced modeling and optimization methods, and 3D-printing technology. We have the goal to provide both implants and surgical planning solutions for healthcare. With the products of ZSFab, we will help to ease the burden of the doctors and release our customers from prolonged pain.  

At ZSFab,  we believe everyone is created equal, but shall be treated differently, when it comes to health care. Each of us is born unique, which is reflected in our DNA, finger prints, faces, and bones. Such uniqueness requires better matching replacement when a part is worn, damaged, or aged. With additive manufacturing, ZSFab is providing accurate planning tools, and structuring, designing, and printing the best medical implants to assist in the healing process for every individual.

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