Mfg Sr Engineer II

Highridge Medical


Date: 1 day ago
City: Westminster, CO
Salary: $89,272 - $117,169 per year
Contract type: Full time
Job Summary

Highridge Medical creates the world’s most innovative spinal solutions across the spectrum from Motion Preservation to MIS to Bone Healing to 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 to demonstrate Confidence in your work and restore Confidence for our patients. Confidence that moves.

The Sr Manufacturing Engineer II will execute cross-functional technical focused projects that deliver exceptional supplier performance and ensure optimal operational readiness across Highridge’s supply chain. This role is responsible for providing technical and strategic manufacturing engineering support to external suppliers. The role is pivotal in driving efficient, high-quality manufacturing solutions for both existing and new products. This role will be accountable for initiatives and projects within three main workstreams: strategic sourcing planning and execution, supplier capability development and improvement, and new product introduction (NPI) supplier readiness

Principal Duties And Responsibilities

  • Take full accountability for high-impact supplier initiatives, consistently achieving cost, quality, compliance, and timeline targets.
  • Facilitate structured, action-oriented meetings that align internal teams (Procurement, Quality, Regulatory, R&D) and external suppliers to ensure seamless execution of project milestones and requirements.
  • Proactively identify potential risks and implement effective mitigation strategies to maintain uninterrupted project progress.
  • Communicate clear, concise project updates to leadership, emphasize risk management and cross-functional alignment.
  • Challenge existing processes and make informed decisions in dynamic environments.
  • Build and sustain strong collaborative relationships with key strategic suppliers to support ongoing business objectives.
  • Strategic Sourcing Execution Workstream
  • Serve as the technical and project lead for product supplier transfer projects, providing hands-on support and proactively identifying opportunities to accelerate timelines and mitigate risks through in-depth review of process validations, manufacturing documentation, and project plans.
  • Supplier Capability & Performance Optimization Workstream
  • Continuously monitor and analyze supplier performance metrics, including on-time delivery, nonconformance rates, and cost trends, in partnership with the Supplier Quality, Sourcing, and Procurement teams.
  • Plan and deliver data-driven improvement initiatives to enhance supplier quality, reduce lead times, expand production capacity, and achieve sustainable cost reductions.
  • Assess supplier-related risks (e.g., financial stability, capacity constraints, delivery reliability) and implement targeted mitigation strategies and projects to ensure consistent and uninterrupted supply chain performance.
  • Deliver should-cost analysis and manufacturing process optimization for components requiring machining, finishing, and assembly to enable cost reduction and improved manufacturability.
  • New Product Introduction (NPI) Implementation Workstream
  • Lead supplier readiness efforts for new product launches, ensuring alignment with manufacturing capabilities, design for manufacturability (DFM), cost targets, capacity requirements, emerging technology integration, and all necessary deliverables.
  • Create and maintain technical documentation including drawings, inspection plans, process routers, and manufacturing procedures per QMS and FDA 21 CFR Part 820 requirements .

This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

Skills

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

Project Management & Operations Expertise

  • Strong knowledge of supply chain and manufacturing operations with expertise in validation and verification activities, design transfer, and risk management.
  • Proven ability to execute multiple complex projects, proactively solving issues and driving timelines.

Problem-Solving Skillset

  • Effective in making sound decisions in dynamic situations with strong judgment and realism.
  • Creative in developing and implementing innovative, resourceful solutions to overcome challenges.

Technical Skillset

  • Working knowledge of medical device regulations (FDA, ISO)
  • Working knowledge of ISO/FDA medical device cleaning and biocompatibility requirements.
  • Deep understanding of process validation, FAI, PPAP, and pFMEA process.
  • Strong understanding of a wide variety of processing applications such as machining, finishing, forging, casting, cleaning, heat treating, bonding, molding, etc
  • Proficiency in interpreting technical drawings and using GD&T
  • Experienced with control procedures, such as the Change Management System, Nonconformance Reports, Engineering Specifications, Corrective and Preventive Action (CAPA), and Work Instructions

Leadership & Influence

  • Leads cross-functional process improvements through collaboration, coaching, and strong interpersonal influence.
  • Builds credibility and trust to drive alignment and achieve shared objectives across diverse internal and external teams.

Communication Skillset

  • Communicates clearly and effectively across levels, using structured messaging with a focus on alignment and impact.

Education/Experience Requirements

  • Bachelor’s degree in engineering required.
  • 5+ years of engineering experience and 1+ years of accountable project lead experience.
  • Experience working with global suppliers in a manufacturing environment.
  • Proven track record and ability to deliver supplier-facing projects in complex, regulated environments.
  • Individual must be motivated self-starter with the ability to work both independently and cross-functionally.
  • Experience with Smartsheet software is preferred.
  • Proficiency in MS Office Applications.
  • Proficiency in CAD software. Solidworks preferred

Travel Requirements

  • Up to 20%

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