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Medical Device Research And Development Jobs in Oregon

... Research & Development, and Marketing teams to translate complex clinical evidence into high ... Expert knowledge of MEDDEV 2.7/1 Rev. 4, European Union Medical Device Regulation (EU MDR 2017/745 ...

This position is primarily focused on new customer acquisition within the medical device OEM and ... Partner closely with Engineering, R&D, Product Development, Operations, and Quality to define ...

This position is primarily focused on new customer acquisition within the medical device OEM and ... intelligence research Identify and qualify new leads through discovery, needs analysis, and ...

New

We have a significant global research, development, manufacturing and commercial footprint of ... medical device or other regulated product development programs. * Strong communication ...

Director, Clinical Development

OR · On-site +1

$75K - $102K/yr

We have a significant global research, development, manufacturing and commercial footprint of ... medical device clinical development, with a strong focus on ophthalmic surgery. * Proven track ...

... medical products based on the latest technology and research. Our success is based on the ... Lead the development and revision of clinical study protocols. * Design case report forms (CRFs) to ...

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Medical Device Research And Development information

What is medical device research and development?

Medical device research and development (R&D) is the process of designing, creating, testing, and improving medical devices used for diagnosing, treating, or preventing health conditions. This field combines engineering, biology, and medicine to develop innovative tools ranging from simple instruments to complex implantable devices. Professionals in this area work on everything from concept development and prototyping to clinical trials and regulatory approval. Their work ensures that medical devices are safe, effective, and meet strict regulatory standards before reaching patients.

What are some typical challenges faced by professionals in medical device research and development, and how can these be managed?

Professionals in Medical Device Research and Development often encounter challenges such as navigating complex regulatory requirements, balancing innovation with safety, and coordinating cross-functional teams. Managing these challenges involves staying current with FDA and international regulations, fostering open communication between engineering, clinical, and regulatory teams, and maintaining rigorous documentation throughout the development process. Strong project management skills and a collaborative mindset are key to overcoming these obstacles and ensuring successful product development.

What are the key skills and qualifications needed to thrive in medical device research and development, and why are they important?

To thrive in Medical Device Research and Development, you need a solid background in engineering or life sciences, along with experience in product design and knowledge of regulatory standards. Familiarity with CAD software, prototyping tools, and compliance systems such as ISO 13485 or FDA regulations is typically required. Strong problem-solving skills, creativity, and effective teamwork set standout professionals apart in this field. These skills and qualities are crucial to ensure innovative, safe, and compliant medical devices that meet both clinical needs and regulatory requirements.

What is the difference between Medical Device Research And Development vs Medical Device Quality Assurance?

AspectMedical Device Research And DevelopmentMedical Device Quality Assurance
CredentialsEngineering degrees, certifications in R&DQuality certifications, regulatory training
Work EnvironmentLabs, design teams, product developmentInspection facilities, compliance departments
Employer & Industry UsageManufacturers, biotech firms, innovation labsRegulatory agencies, manufacturing companies
Search & Comparison IntentInnovation, product development, prototypingCompliance, testing, product validation

Medical Device Research And Development focuses on designing and developing new medical devices, emphasizing innovation and prototyping. In contrast, Medical Device Quality Assurance ensures products meet safety and regulatory standards through testing and compliance. Both roles are essential in the medical device industry but serve different stages of the product lifecycle.

What are popular job titles related to Medical Device Research And Development jobs in Oregon?

For Medical Device Research And Development jobs in Oregon, the most frequently searched job titles are:

What job categories do people searching Medical Device Research And Development jobs in Oregon look for?

The top searched job categories for Medical Device Research And Development jobs in Oregon are:

Infographic showing various Medical Device Research And Development job openings in Oregon as of August 2026, with employment types broken down into 1% As Needed, 75% Full Time, 18% Part Time, and 6% Contract. Highlights an 89% Physical, 1% Hybrid, and 10% Remote job distribution.

Senior Staff Medical Writer (Remote)

Stryker

Portland, OR • On-site, Remote

$143K - $238K/yr

Full-time

Posted 20 days ago


Key responsibilities

  • Author and maintain clinical and regulatory documentation such as Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-Up (PMCF) documents.

  • Compile, analyze, and synthesize clinical evidence from various sources into submission-ready regulatory documents.

  • Collaborate with cross-functional teams to develop clinical evidence strategies, regulatory documentation plans, and project timelines.


Stryker rating

8.2

Company rating: 8.2 out of 10

Based on 112 frontline employees who took The Breakroom Quiz

134th of 499 rated machine equipment manufacturers


Job description

Work Flexibility: Remote

Stryker is hiring a Senior Staff Medical Writer to join our Endoscopy Division, to be based remotely anywhere within the United States. Stryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better. Our Endoscopy Division delivers a diverse array of innovative medical technologies to support minimal invasive surgery through brilliant visualization, connected OR solutions, sports medicine products to sustainability solutions.

As the Senior Staff Medical Writer, you will develop scientific and clinical documentation that supports global regulatory compliance and market access for medical devices. This position partners closely with Regulatory Affairs, Clinical Affairs, Quality, Research & Development, and Marketing teams to translate complex clinical evidence into high-quality regulatory and scientific documents throughout the product lifecycle.

What You Will Do

  • Author and maintain Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF) documents, and other clinical evidence documentation supporting international product registrations and lifecycle management.

  • Compile, analyze, and synthesize clinical evidence from clinical studies, published literature, post-market data, and other safety and performance sources into submission-ready regulatory documents.

  • Respond to notified body reviews and regulatory feedback, driving resolution of clinical documentation questions to support ongoing market access.

  • Collaborate with cross-functional teams to develop clinical evidence strategies, regulatory documentation plans, and project timelines.

  • Author clinical study protocols, study reports, data summaries, and supporting scientific documents for regulatory and clinical initiatives.

  • Conduct systematic literature reviews, evaluate scientific data, and integrate findings into clinical and regulatory documentation.

  • Lead document review cycles, coordinate stakeholder feedback, resolve content issues, and obtain timely approvals.

  • Drive continuous improvement initiatives, maintain medical writing tools and templates, and mentor junior medical writing team members.

What You Need

Required

  • Bachelor's degree in a scientific, technical, healthcare, or related discipline.

  • Minimum 6 years of industry experience within medical technology, medical devices, pharmaceuticals, or healthcare products.

  • Minimum 4 years of experience in scientific writing, medical writing, clinical research, or related regulatory documentation activities.

  • Experience authoring Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-Up (PMCF) documentation.

  • Expert knowledge of MEDDEV 2.7/1 Rev. 4, European Union Medical Device Regulation (EU MDR 2017/745), and Medical Device Coordination Group (MDCG) guidance for clinical evaluations.

  • Experience conducting systematic literature reviews and utilizing scientific databases, literature search methodologies, and literature management tools.

  • Knowledge of FDA, Good Clinical Practice (GCP), ISO 14155, ISO 14971, and applicable international medical device regulations and standards.

Preferred

  • Master's degree, PhD, PharmD, MD, MPH, RN, BSN, or other advanced health-related degree.

  • Experience authoring clinical study protocols, clinical study reports, manuscripts, or scientific publications.

  • Experience supporting regulatory submissions and global market access initiatives for medical devices.

  • Knowledge of clinical operations, risk management, and international regulatory requirements.

United States of America Pay Ranges:

  • USN: $110,100 - $183,400 USD Annual
  • US5: $115,600 - $192,600 USD Annual
  • US10: $121,100 - $201,700 USD Annual
  • US15: $126,600 - $210,900 USD Annual
  • US20: $132,100 - $220,100 USD Annual
  • US30: $143,100 - $238,400 USD Annual
View the U.S. work location and transparency guide to find the pay range for your location.

Travel Percentage: 10%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.

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