Medical Device Analyst Jobs in Colorado (NOW HIRING)

Highridge Medical creates the world's most innovative spinal solutions across the spectrum from Motion Preservation to Minimally Invasive Surgeryto Core Spine.

Working at Highridge Medical is not just work. Life at Highridge Medical is purpose driven. Every day, you have the privilege of using your talents todemonstrateConfidence in your work and restore Confidence for our patients. Confidence that moves.

JobSummary:

We are seeking a Project Manager to lead cross-functional teams through the full product development lifecycle, from concept through commercialization within the R&D Department. This roleis responsible forproject planning, schedule management, risk mitigation, and ensuring compliance with design control and quality system requirements. The NPD Project Manager will partner closely with Engineering, Marketing, Regulatory, Quality, Operations, Clinical, and Supply Chain to deliver innovative spinal implant and instrument solutions on time and within scope. Occasional travel may berequired.

Principal Duties and Responsibilities:

Leads the planning of new product development projects using structured phase-gate and design control processes common to the medical device industry.

Develops andmaintainsdetailed Gantt charts, project schedules, resource plans, and critical path analyses.

Facilitatescross-functional collaboration across Engineering, Marketing, Regulatory, Quality, Operations, Clinical, Testing, and Supply Chain to ensure alignment on requirements, deliverables, and timelines.

Leads project meetings, including kickoffs, weekly status reviews, technical reviews, and phase-gate approvals; prepares agendas, documents minutes, assigns action items, and drives accountability.

Tracks project progress,identifiesrisks, and implements mitigation strategies to ensure successful execution.

Supports the completion of project documentation that isaccurate, and compliant within the Design History File (DHF).

Supports the development and refinement of user needs, product requirements, and system specifications by coordinating input from surgeons, marketing, and engineering teams.

Coordinates with Regulatory Affairs to ensure project deliverables support global submissions and compliance requirements.

Works with Operations and Supply Chain to support manufacturing readiness, pilot builds, process validation, and launch planning.

Prepares and presents project updates, dashboards, and risk assessments to leadership and executive stakeholders.

Manages multiple concurrent projects and adjusts plans to meet evolving business priorities.

This is not an exhaustive list of duties or functions and may not necessarilycompriseall ofthe "essential functions" for purposes of the ADA.

Expected Areas of Competence (i.e., knowledge, skills, and abilities):

Strong working knowledge of medical device product development, including design control, risk management, and quality system requirements.

Demonstratedability to lead cross-functional teams and influence without direct authority, consistent with practices at leading device manufacturers.

Demonstratedcreativity and ability to takeactionsin solving problems and making decisions in a dynamic and evolving environment.

Proficiencyin developing and managing complex project schedules, resource plans, and risk registers.

Ability to communicate effectively with technical and non-technical stakeholders, including surgeons, engineers, executives, and external partners.

Strong organizational skills with the ability to manage multiple high-complexity projects simultaneously.

Experience preparing and delivering executive-level presentations and project status reports.

Proficiencywith MS Project, Smartsheet, or equivalent project management tools; strong skills in Microsoft Office Suite.

Familiarity with manufacturing processes, design for manufacturability, and supply chain considerations for implant and instrument systems.

Experience in a regulated medical device environment (Class II/III preferred)

Education/Experience Requirements:

MinimumB.S. degree in Engineering, Project Management, Business, or related field.

3+ years of experience in project management, preferably within the medical device industry or other regulated product development environments.

Experience managing cross-functional teams and complex product development projects.

PMP certification or equivalent is a plus.

Please visit Highridgemedical.com foradditionalinformation.

Highridge Medical is an equal opportunity employer committed to diversity and inclusion in the workplace. All qualified applicants for employment and employment decisionsareconsidered and evaluated without regard to race, color, religion, religious beliefs, creed, national origin, ancestry, citizenship status, age, gender, sex (including pregnancy, childbirth, related medical conditions, lactation and breastfeeding), gender identity or expression (including transgender status), sexual orientation, marital status, military status,protected veteran status, disability, protected medical condition as defined by applicable state or local law, genetic information, or any other status protected under applicable federal, state, and local laws.