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Combination Product Medical Device Engineer Jobs in Kansas

Senior Systems Engineer

Olathe, KS

$98K - $135K/yr

Lead systems engineering activities, including requirements development, system architecture, and product design for medical device projects. * Collaborate with cross-functional teams, including ...

Senior Systems Engineer

Olathe, KS · On-site

$98K - $135K/yr

Lead systems engineering activities, including requirements development, system architecture, and product design for medical device projects. * Collaborate with cross-functional teams, including ...

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Sr. Systems Engineer

Olathe, KS · On-site

$101K - $138K/yr

Lead systems engineering activities, including requirements development, system architecture, and product design for medical device projects. * Collaborate with cross-functional teams, including ...

Be Seen First

Sr. Systems Engineer

Olathe, KS · On-site

$101K - $138K/yr

Lead systems engineering activities, including requirements development, system architecture, and product design for medical device projects. * Collaborate with cross-functional teams, including ...

Senior Systems Engineer

Olathe, KS · On-site

$101K - $138K/yr

Lead systems engineering activities, including requirements development, system architecture, and product design for medical device projects. * Collaborate with cross-functional teams, including ...

Senior Systems Engineer

Lenexa, KS

$101K - $138K/yr

Lead systems engineering activities for medical device projects, including requirements development, system architecture definition, and product design for electromechanical and embedded systems.

Senior Systems Engineer

Olathe, KS · On-site

$98K - $135K/yr

Lead systems engineering activities, including requirements development, system architecture, and product design for medical device projects. * Collaborate with cross-functional teams, including ...

Senior Mechanical Engineer

Olathe, KS · On-site

$90 - $120/hr

... production quality medical device. * Participate in technical design and design review meetings to discuss challenges related to the medical device. * Work closely with electrical and firmware ...

Senior Mechanical Engineer

Olathe, KS · On-site

$98K - $130K/yr

... production quality medical device. * Participate in technical design and design review meetings to discuss challenges related to the medical device. * Work closely with electrical and firmware ...

Senior Mechanical Engineer

Olathe, KS · On-site

$120 - $190/hr

... production quality medical device. * Participate in technical design and design review meetings to discuss challenges related to the medical device. * Work closely with electrical and firmware ...

... engineers with SaMD (Software as a Medical device) in technical capacity which can include product ... Through our unique combination of consulting, training, assurance and regulatory services we bring ...

Senior Mechanical Engineer

Olathe, KS · On-site

$98K - $130K/yr

... production quality medical device. * Participate in technical design and design review meetings to discuss challenges related to the medical device. * Work closely with electrical and firmware ...

... engineers with SaMD (Software as a Medical device) in technical capacity which can include product ... Through our unique combination of consulting, training, assurance and regulatory services we bring ...

Senior Mechanical Engineer

Olathe, KS · On-site

$101K - $133K/yr

... production quality medical device. * Participate in technical design and design review meetings to discuss challenges related to the medical device. * Work closely with electrical and firmware ...

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Combination Product Medical Device Engineer information

What is a combination product medical device engineer?

Combination Product Medical Device Engineers are professionals who design, develop, and oversee the manufacturing of medical products that integrate drugs, devices, and/or biological components. They ensure these products meet regulatory standards and function safely and effectively for patients. Their work often involves cross-disciplinary collaboration, detailed documentation, and rigorous testing to comply with FDA or other international requirements. These engineers play a crucial role in bringing innovative combination therapies and delivery systems to market.

What are some typical challenges faced by a combination product medical device engineer when working on cross-functional teams?

Combination Product Medical Device Engineers often collaborate with professionals from pharmaceutical, biotechnology, and device engineering backgrounds. One common challenge is ensuring clear communication across disciplines, as each team may have different regulatory requirements and technical needs. Balancing the integration of drug and device components while meeting strict FDA and ISO standards can also be complex. Proactively addressing these challenges through regular cross-functional meetings and thorough documentation helps ensure project success and compliance.

What are the key skills and qualifications needed to thrive as a combination product medical device engineer, and why are they important?

To thrive as a Combination Product Medical Device Engineer, you need a strong background in biomedical or mechanical engineering, familiarity with drug delivery systems, and experience in regulatory standards like FDA 21 CFR and ISO 13485. Proficiency with CAD software, risk management tools, and knowledge of quality management systems (QMS) are typically required, along with certifications such as Six Sigma or PMP being advantageous. Strong problem-solving abilities, attention to detail, and effective cross-functional communication are critical soft skills for excelling in this role. These competencies ensure the development of safe, compliant, and innovative combination products that meet both technical and regulatory requirements.

What is the difference between Combination Product Medical Device Engineer vs Medical Device Quality Engineer?

AspectCombination Product Medical Device EngineerMedical Device Quality Engineer
CredentialsBachelor's or higher in engineering, regulatory knowledgeBachelor's or higher, quality standards expertise
Work EnvironmentDesign, development, and testing of combination productsQuality assurance, compliance, and validation processes
Industry UsagePharmaceutical and medical device sectors involving combination productsMedical device manufacturing and regulatory compliance

The Combination Product Medical Device Engineer focuses on designing and developing products that integrate drugs, devices, or biologics, requiring cross-disciplinary skills. In contrast, the Medical Device Quality Engineer emphasizes ensuring product quality, compliance, and validation throughout manufacturing. Both roles are essential in the medical device industry but serve different stages of product lifecycle and expertise areas.

What are popular job titles related to Combination Product Medical Device Engineer jobs in Kansas?

For Combination Product Medical Device Engineer jobs in Kansas, the most frequently searched job titles are:

What job categories do people searching Combination Product Medical Device Engineer jobs in Kansas look for?

The top searched job categories for Combination Product Medical Device Engineer jobs in Kansas are:

Senior Med Device Mechanical Engineer

Olathe, KS

Actalent
Business Management Consulting • 5 - 10K employees

$120K - $140K/yr

Full-time

Posted 10 days ago


Job description

Job Title: Sr. Mechanical Engineer

Job Description

We are seeking a Sr. Mechanical Engineer to lead the design, development, testing, and implementation of innovative medical devices. This individual will drive projects from concept and prototype through production release while collaborating closely with electrical and firmware engineering teams.

Responsibilities

  • Develop mechanical architecture for medical devices.
  • Conduct product testing and manage manufacturing transfer.
  • Engage in sustaining engineering and documentation creation.
  • Provide regulatory support and drive continuous improvement initiatives.
  • Offer technical leadership and mentor team members.
  • Manage multiple concurrent development projects in a fast-paced medical device environment.

Essential Skills

  • Product development engineering experience.
  • Mechanical design engineering expertise.
  • Proficiency in Solidworks.
  • Experience with electro-mechanical systems.
  • Bachelor's in Mechanical Engineering.
  • Full product lifecycle experience from concept through commercialization.
  • Designing FDA-regulated products.
  • Understanding of design controls and regulatory requirements.
  • Tolerance analysis and material selection, especially sheet metal and plastics.
  • Design for manufacturability.

Additional Skills & Qualifications

  • Technical leadership experience.
  • Mentoring Junior Engineers.
  • Project ownership and regulatory compliance.
  • Finite Element Analysis (FEA) and machine shop experience.
  • Geometric Dimensioning and Tolerancing (GD&T) and design verification.
  • Master's in Mechanical Engineering is preferred.
  • 10+ years of Mechanical Engineering experience.
  • 5+ years of Medical Device experience with other industry exposure.
  • Experience in a regulated environment.

Work Environment

This is an on-site role for at least the first 6 months, with the potential for work-from-home options thereafter. The position offers flexible working hours, totaling 40 hours per week. You will have access to cutting-edge technology and a variety of projects, providing a wide range of experience.

Job Type & Location

This is a Permanent position based out of Olathe, KS.

Pay and Benefits

The pay range for this position is $120000.00 - $140000.00/yr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Company has a competitive benefit package

Workplace Type

This is a fully onsite position in Olathe,KS.

Application Deadline

This position is anticipated to close on Sep 1, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance:Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector:It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.


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About Actalent

Sourced by ZipRecruiter

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

Industry

Business management consulting

Company size

5,001 - 10,000 Employees

Headquarters location

Hanover, MD, US

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