Skip to content

Open nowPosted 11 days ago

Sr. Sustaining Engineer I

Highridge Medical16 open roles

Pay
$85,000 – $100,000 a year
Where
US CO Westminster
Get the CV for this job

From $25 per CV, paid once. No subscription.

Your applicationOpen nowSr. Sustaining Engineer IHighridge Medical · US CO Westminster
  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on Highridge Medical's own form.

The reply lands in your private mailbox

3×more interviews than doing it yourself with ChatGPT.

The clock on this job

Early applications get read.

8.3% of postings close within 7 days. Measured by our own scanner across the market. Highridge Medical postings stay open a median of 29 days.

Share of postings closed within
  1. 1.9%1 day
  2. 4.0%3 days
  3. 8.3%7 days
  4. 15.3%14 days
  5. 34.2%30 days
This job: posted 11 days ago

Highridge Medical median: 29 days open

The posting

Sr. Sustaining Engineer I

Highridge Medical creates the world’s most innovative spinal solutions across the spectrum from Motion Preservation to MIS to Complex Deformity 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.

We are seeking a Senior I Sustaining Engineer responsible for the technical support, maintenance, and continuous improvement of post-production spinal implants, instruments, and systems throughout the product lifecycle. This engineer leads small- to medium-scope sustaining projects with increasing autonomy and serves as a technical contributor on larger cross-functional efforts. The role partners with Quality, Regulatory, Manufacturing, Supply Chain, Supplier Quality, Testing, Marketing, and Sales to resolve product and production issues, implement compliant design and documentation changes, maintain product performance and availability, and improve quality, manufacturability, reliability, and cost. Occasional interaction with surgeons, suppliers, and external test laboratories, as well as mentoring of junior engineers, may be required.

Principal Duties and Responsibilities:

· Leads sustaining engineering projects for released spinal implants, instruments, and production-transferred parts, from issue definition through implementation and closure.

· Provides day-to-day technical support to Manufacturing, Quality, Supply Chain, and suppliers to maintain product availability, quality, and production continuity.

· Reviews and evaluates nonconforming product, customer complaints, field returns, scrap, yield loss, and process variability; provides technically sound dispositions and recommendations.

· Leads or supports root cause investigations and development-related CAPAs using structured problem-solving, risk-based decision making, and appropriate statistical methods.

· Creates and manages Engineering Change Requests/Orders through completion, including updates to specifications, drawings, bills of material, inspection requirements, labeling, work instructions, and related records.

· Updates CAD models and engineering drawings, primarily in SolidWorks, and applies GD&T and design-for-manufacturability, inspectability, reliability, and cost principles.

· Plans and executes product and process evaluations, design verification and validation, test method validation, and manufacturing process validation, as applicable; authors protocols, reports, and technical justifications.

· Maintains and remediates post-launch design control and risk-management documentation, including DHF and technical-file records, risk analyses, inspection plans, protocols, and reports.

· Supports post-market surveillance and regulatory activities by supplying technical assessments and documentation for global registrations, field actions, and product lifecycle decisions.

· Identifies and implements product, supplier, and manufacturing improvements that reduce risk, scrap, cycle time, and cost while maintaining validated performance and regulatory compliance.

· Coordinates technical work with suppliers, contractors, and test laboratories; supports supplier changes, component obsolescence, alternate-source qualification, and production transfers.

· Develops project plans, manages priorities and timelines, communicates risks and status, and drives cross-functional actions to timely closure.

· Provides technical guidance and may mentor junior engineers or technicians on sustaining engineering methods, documentation, and investigations.

This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.

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

· Working knowledge of the post-launch medical device lifecycle, design controls, risk management, change control, and production-transfer requirements.

· Demonstrated ability to independently investigate technical problems, determine root cause, assess risk, and implement effective corrective actions.

· Experience evaluating complaints, nonconforming product, manufacturing trends, and supplier issues and translating findings into clear engineering decisions.

· Ability to plan and document verification, validation, product evaluation, and process-validation activities using objective evidence and sound statistical methods.

· Ability to develop and maintain project schedules, balance multiple priorities, and drive cross-functional tasks to completion with limited supervision.

· Strong working knowledge of manufacturing processes, inspection methods, design for manufacturability, and continuous-improvement principles for machined or manufactured medical devices.

· Proficient in CAD design and engineering drawings, preferably using SolidWorks, with working knowledge of drafting standards and GD&T.

· Familiarity with FDA Quality System requirements, ISO 13485, ISO 14971, and other regulations and standards applicable to orthopedic medical devices.

· Ability to analyze data, identify trends, and use structured problem-solving tools; familiarity with Lean, Six Sigma, DOE, SPC, capability analysis, or statistical software is preferred.

· Professional, concise, and tactful communication with internal teams and external stakeholders, including suppliers, test laboratories, surgeons, and regulatory partners.

· Proficient with Microsoft Office Suite and project-tracking tools; able to create clear technical reports and present recommendations to cross-functional teams and leadership.

Education/Experience Requirements

· Minimum B.S. degree from an ABET accredited school (or global equivalent) in one of the following engineering disciplines: Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, Bioengineering, Biomedical Engineering Technology, Bioengineering Technology, Aerospace Engineering or Aeronautical Engineering.

· 3-7 years of relevant engineering experience, preferably in medical device sustaining engineering, manufacturing engineering, product development, or lifecycle management; experience with orthopaedic implants and instruments is preferred.

· Preferred: Experience developing spine or other medical devices, including implants and instruments.

Travel Requirements

Up to 10%

Salary Range $85,000.00- 100,000.00 DOE

From $25, paid onceGet the CV for this job

What happens when you press

One press. We do the rest.

  1. A CV for this posting

    Written against Highridge Medical's own wording, from every piece of relevant proof in your profile.

  2. 25 readers review it

    Recruiter, hiring manager, skeptic and more read every draft, round after round. You get the best round.

    The review screen in CV Rocket: how each CV was read, round by round.
  3. We apply on Highridge Medical's form

    Our application engine gets through the hardest forms there are. Where a question needs you, AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

    An application in CV Rocket: every answer filled in on the employer's form.
  4. Every reply, sorted

    Highridge Medical's answer lands in your private mailbox, and we classify it on arrival: interview, question, rejection.

    The CV Rocket inbox: each employer reply classified as an interview, an action or a rejection.
  5. Reply with AI

    AI helps you write the email, checks it and sends it. We show you whether the recruiter read it.

  6. The interview in your calendar

    Full integration with your calendar. The invitation goes straight in.

    An interview invitation in the CV Rocket inbox, added to the candidate's calendar.
Get the CV for this job

From $25 per CV, paid once. No subscription.

Why it works

3×

more interviews than doing it yourself with ChatGPT.

ChatGPT writes a CV and never learns what happened to it. We see every reply. For each CV we know:

  • How it was written, and how the review scored it
  • When we applied, and how long after the posting went up
  • Which posting, which company, which city
  • Who got the interview, and who heard nothing

That is how we know which CVs get called.

Get the CV for this job

From $25 per CV, paid once. No subscription.

The numbers game

More applications. More interviews.

Every application goes out with its own CV, written for that posting and paid once. Send enough of them and the law of large numbers finds you the job.

By hand5–10
With CV Rocket100
applications a day

Nearby

Live postings like this one

Same employer first, then the same role elsewhere.

Before you press

Straight answers

Get the CV for this job

From $25 per CV, paid once. No subscription.

What if my background isn't good enough?

We make the most of the background you have. The CV uses every piece of relevant proof your profile holds, and one of the 25 readers reads your whole profile and flags what the CV left out.

Do you really apply for me?

Yes, on the employer's own form, the hardest ones included. Where a question needs you, you answer it right there and AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

Is it a subscription?

No. You pay once per CV, from $25. Every application goes out with its own CV, written for that posting.

One job. One CV.
Paid once.

Pick the posting you want. We write for it, apply for you and catch the reply.

Get the CV for this job

From $25 per CV, paid once. No subscription.