Engineering Manager

Nexxt Spine•Noblesville, IN

11d

About The Position

Nexxt Spine LLC is a medical device company that designs, manufactures, and distributes spinal implants and instruments. The Engineering Manager ensures each project has a clearly defined scope and a confirmed completion. The role translates surgeon concepts into project scope and owns plans from concept through 510(k) clearance and production release, while holding the engineering team accountable for completing project phases. It supervises engineers from Engineer I through Lead Engineer and establishes standards for project scoping, tracking, and closure; engineers retain ownership of technical design work. The manager creates project charters and integrated plans, approves measurable and traceable design inputs with Senior Engineers, establishes phase gates, and manages scope changes and project status. The role tracks projects, coordinates testing and regulatory submissions, verifies design history file completeness, manages production handoff, and closes projects with documented reviews and archived records. The position supervises and develops the engineering team, including hiring, onboarding, performance reviews, goal setting, workload balancing, feedback, and career development. It also works with the Lead Engineer to ensure consistent technical reviews, mentoring, and design standards, and models effective communication with surgeons and cross-functional partners.

Requirements

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 sufficient to assess technical progress and risk.
Clear written and verbal communication with audiences ranging from surgeons to executive leadership.
Critical thinking and creative problem-solving skills for weighing schedule, cost, and technical trade-offs.
Bachelor of Science degree in Engineering.

Nice To Haves

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

Responsibilities

Translate surgeon concept meetings into written project charters defining scope, intended use, deliverables, and success criteria before design work begins.
Approve design inputs with Senior Engineers so requirements are measurable, testable, and traceable to user needs.
Build integrated project plans for implant and instrument systems, covering CAD design, prototyping, testing, patents, 510(k), and production transfer.
Define phase gates and entry and exit criteria, including concept review, design freeze, verification and validation, regulatory submission, and launch.
Assign owners and due dates to deliverables and communicate expected outputs and completion standards.
Manage scope changes through a documented process that records impacts on schedule, cost, testing, and regulatory pathway.
Publish a reliable, single source of truth for project status for surgeons and cross-functional partners.
Track project progress weekly against baseline plans, identify schedule slips, and drive recovery actions to closure.
Run phase gate reviews and verify exit criteria are met before projects advance; document open items.
Coordinate FDA testing with internal laboratories and external test houses so mechanical testing to ASTM standards is completed on schedule for 510(k) submission.
Partner with regulatory staff to plan submission dates, track FDA questions, and close responses within agreed timelines.
Confirm DHF completeness at project gates and close so design records are audit-ready under FDA, GMP, and ISO 13485 requirements.
Manage manufacturing handoff, including design transfer, supplier readiness, and first production builds.
Maintain project risk and issue logs and escalate unresolved blockers.
Close projects with a completion review, lessons learned, and archived records.
Supervise 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 engineer's level and independence.
Hold engineers accountable for timely, complete deliverables and provide 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 consistent technical design reviews, mentoring, and design standards.
Model clear communication with surgeons and cross-functional partners and coach engineers to do the same.