Engineering Manager

Nexxt Spine, LLC; Noblesville (IN); On-site; USD 120,000 - 165,000; Full time

Job summary

Nexxt Spine, LLC, a leader in spinal implants and instruments, seeks an Engineering Manager to translate surgeon concepts into defined scope and deliverables. You will guide the engineering ladder from Engineer I to Lead Engineer, ensuring phase gates, regulatory milestones, and production transfers are met.

In this role you will own project plans, coordinate FDA testing, and manage cross-functional teams to deliver compliant, high-quality implants and instruments on schedule.

Qualifications

• Experience taking implants or instruments from concept through 510(k) clearance and production release.
• Supervisory or project leadership over engineers at multiple levels.
• Knowledge of FDA design controls, GMP, ISO 13485, and DHF requirements.
• Proficiency with project planning tools, schedules, phase gates, and risk logs.
• Hands-on understanding of SolidWorks, additive manufacturing, and ASTM testing.
• Clear written and verbal communication across levels.
• Strong analytical and problem-solving skills for trade-offs.

Responsibilities

• Translate surgeon concepts into defined project charters and scope.
• Own plan from concept to 510(k) clearance and production release.
• Supervise engineers from entry to lead roles and set milestones.
• Publish a single source of project status for stakeholders.
• Coordinate phase gates and exit criteria for project progression.

Skills

Project management

Leadership

FDA design controls

Regulatory planning

SolidWorks

Additive manufacturing

Problem solving

Communication

Education

Bachelor of Science in Engineering

Tools

SolidWorks

3D Printing

Mechanical testing

Job description

Nexxt Spine LLC, is a leader in the medical device industry, dedicated to designing, manufacturing, and distributing an expanding portfolio of innovative spinal implants and instruments. We are committed to a culture of innovation, excellence, and employee engagement while delivering solutions that improve patient outcomes and strengthen surgeon and distributor partnerships.

JOB DESCRIPTION

The Engineering Manager makes sure every spinal implant and instrument project has a clear definition at the start and a confirmed finish at the end. The role turns surgeon concepts into defined scope, owns the plan from concept through 510(k) clearance and production release, and holds the engineering team accountable for closing each phase.

The role supervises the full engineering ladder, from Engineer I through Lead Engineer. It sets the standard for how projects are scoped, tracked, and closed, while the engineers own the technical design work.

ESSENTIAL DUTIES: Project Clarity

• Translate surgeon concept meetings into a written project charter with scope, intended use, deliverables, and success criteria before design work begins.
• Approve design inputs with the Senior Engineers so every requirement is measurable, testable, and traceable to user needs.
• Build an integrated project plan for each implant and instrument system, covering CAD design, prototyping (3D printing, SLA, machining), testing, patents, 510(k), and production transfer.
• Define phase gates and the entry and exit criteria for each, including concept review, design freeze, verification and validation, regulatory submission, and launch.
• Assign clear owners and due dates to every deliverable, and confirm each engineer understands the expected output and standard of completion.
• Manage scope changes through a documented change process that records impact on schedule, cost, testing, and regulatory pathway.
• Publish a single source of truth for project status that surgeons, regulatory, quality, manufacturing, and sales can rely on.

ESSENTIAL DUTIES: Project Completion

• Track progress weekly against the baseline plan, identify slips early, and drive recovery actions to closure.
• Run phase gate reviews and confirm exit criteria are met before a project advances; do not allow open items to carry forward undocumented.
• Coordinate FDA testing with internal labs and external test houses so mechanical testing to ASTM standards finishes on schedule for 510(k) submission.
• Partner with regulatory to plan submission dates, track FDA questions, and close responses within agreed timelines.
• Confirm DHF completeness at each gate and at project close, so design records are audit-ready under FDA, GMP, and ISO 13485.
• Manage handoff to manufacturing, including design transfer, supplier readiness, and first production builds.
• Maintain a risk and issue log for each project and elevate blockers that the team cannot resolve.
• Close every project formally with a completion review, lessons learned, and archived records.

SUPERVISORY RESPONSIBILITIES

• Supervise the Lead Engineer, Senior Engineer II, Senior Engineer I, Engineer II, and Engineer I positions, including hiring, onboarding, and performance reviews.
• Set individual goals tied to project milestones, and hold regular one-on-ones to review progress and remove obstacles.
• Balance workload across concurrent projects and match assignments to each level's scope and independence.
• Hold engineers accountable for on-time, complete deliverables while giving clear, specific feedback on quality.
• Support career growth along the Engineer I to Lead Engineer ladder, including promotion readiness and development plans.
• Work with the Lead Engineer to ensure technical design reviews, mentoring, and design standards are applied consistently.
• Model clear communication with surgeons and cross-functional partners, and coach engineers to do the same.

QUALIFICATIONS

Required

• Experience taking implants or instruments from concept through 510(k) clearance and production release.
• Prior supervisory or project leadership experience over engineers at multiple levels.
• Working knowledge of FDA design controls, GMP, ISO 13485, and DHF requirements.
• Proficiency with project planning tools and methods, including schedules, phase gates, and risk logs.
• Hands‑on understanding of SolidWorks, additive manufacturing, and mechanical testing to ASTM standards, enough to judge technical progress and risk.
• Clear written and verbal communication at all levels, from surgeons to executive leadership.
• Critical thinking and creative problem solving when weighing schedule, cost, and technical trade‑offs.

Preferred

• PMP or equivalent project management certification.
• Spinal implant or orthopedic device experience.
• Experience with patent processes.
• Background in traditional manufacturing or laboratory research.

EDUCATION

• Bachelor of Science Degree in Engineering

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.