Medical Device Design Controls & Remediation Engineer

Amaris Consulting; Bothell (WA); On-site; USD 95,000 - 135,000; Full time

Benefits offered by this job

Global training program

Industry-leading academy

Team events and international team

Job summary

Amaris Consulting in Bothell, WA seeks dynamic Life Sciences consultants to help remediate design control gaps and drive regulatory-compliant verification across medical device families. You will author and update DFMEA/PFMEA/UFMEA, manage risk analyses, and ensure traceability from business needs to verification evidence, using leading ALM tools.

Candidates bring 3–7+ years in regulated medical device development, strong writing and cross-functional collaboration skills, and fluency in English

Qualifications

• Bachelor’s or Master’s degree in Biomedical, Systems, Mechanical, Electrical Engineering, or a related engineering discipline.
• 3–7+ years of experience in medical device product development within a regulated design controls environment.
• Strong hands-on experience with ISO 14971 risk management, including DFMEA, PFMEA, UFMEA, and Risk Management Matrix (RMM) activities.
• Proven experience authoring verification and validation protocols, reports, requirements specifications, and traceability documentation.
• Working knowledge of FDA Design Controls / 21 CFR 820.30, ISO 13485, and ALM/requirements management tools such as CodeBeamer, Polarion, IBM DOORS, or Windchill.

Responsibilities

• Identify and remediate gaps between user needs, design requirements, risk analyses, and verification/validation evidence across multiple medical device product families.
• Author and update design control documentation, including requirements specifications, DFMEA, PFMEA, UFMEA, Risk Management Matrices (RMM), and V&V protocols and reports.
• Build and repair end-to-end requirements traceability from business, user, and regulatory requirements through verification evidence and product documentation.
• Develop verification and validation test protocols where evidence is missing, ensuring compliance with FDA and ISO design control requirements.
• Prepare and structure remediated documentation for migration from legacy systems (e.g., Windchill) into CodeBeamer or other ALM platforms.
• Track remediation activities, documentation gaps, deliverables, and program metrics using Azure DevOps and communicate progress to program stakeholders.

Skills

ISO 14971 risk management

Technical writing

English fluency

Cross-functional collaboration

3-7+ years medical device experience

Education

Bachelor’s or Master’s degree in Biomedical, Systems, Mechanical, or Electrical Engineering

Tools

CodeBeamer

Polarion

IBM DOORS

Windchill

Job description

Job Description

We are looking for dynamic consultants to grow our Life Sciences team in Bothell, Washington. Your experience, knowledge, and commitment will help us to face our client's challenges.

Your main responsibilities

• Identify and remediate gaps between user needs, design requirements, risk analyses, and verification/validation evidence across multiple medical device product families.


• Author and update design control documentation, including requirements specifications, DFMEA, PFMEA, UFMEA, Risk Management Matrices (RMM), and V&V protocols and reports.


• Build and repair end-to-end requirements traceability from business, user, and regulatory requirements through verification evidence and product documentation.


• Develop verification and validation test protocols where evidence is missing, ensuring compliance with FDA and ISO design control requirements.


• Prepare and structure remediated documentation for migration from legacy systems (e.g., Windchill) into CodeBeamer or other ALM platforms.


• Track remediation activities, documentation gaps, deliverables, and program metrics using Azure DevOps and communicate progress to program stakeholders.

Qualifications

• Bachelor’s or Master’s degree in Biomedical, Systems, Mechanical, Electrical Engineering, or a related engineering discipline.


• 3–7+ years of experience in medical device product development within a regulated design controls environment.


• Strong hands-on experience with ISO 14971 risk management, including DFMEA, PFMEA, UFMEA, and Risk Management Matrix (RMM) activities.


• Proven experience authoring verification and validation protocols, reports, requirements specifications, and traceability documentation.


• Working knowledge of FDA Design Controls / 21 CFR 820.30, ISO 13485, and ALM/requirements management tools such as CodeBeamer, Polarion, IBM DOORS, or Windchill.


• Excellent technical writing, analytical, organizational, and communication skills, with professional fluency in English and the ability to work effectively in a cross-functional hybrid environment.

Why choose us

• An international community bringing together more than 110 different nationalities


• An environment where trust is central: 70% of our leaders started their careers at the entry level


• A strong training system with our internal Academy and more than 250 modules available


• A dynamic work environment that frequently comes together for internal events (afterworks, team buildings, etc.)

Amaris Consulting promotes equal opportunities.

We are committed to bringing together people from diverse backgrounds and creating an inclusive work environment.

In this regard, we welcome applications from all qualified individuals, regardless of sex, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.

Who are we?

Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

Recruitment Process

Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!

Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!

Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.

As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.

We look forward to meeting you!