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Contract Medical Device Software Engineer Jobs in New York

Clarapath Inc

Embedded Software Engineer

Hawthorne, NY

$115K - $155K/yr

Embedded Software Engineer LOCATION: Hawthorne, NY (on-site) TYPE : Full time, regular COMPENSATION ... We are looking for a team player who views medical device development as a competitive advantage.

Clarapath, Inc.

Embedded Software Engineer

Hawthorne, NY · On-site

$115K - $155K/yr

Embedded Software Engineer LOCATION: Hawthorne, NY (on-site) TYPE : Full time, regular COMPENSATION ... We are looking for a team player who views medical device development as a competitive advantage.

Clarapath

Embedded Software Engineer

Hawthorne, NY · On-site

$138K - $182K/yr

We are looking for a Software Engineer who will assist in the development of our next generation ... Develop software for medical device within a well-established robotics framework. * Driver ...

Clarapath

Embedded Software Engineer

Hawthorne, NY · On-site

$138K - $182K/yr

We are looking for a Software Engineer who will assist in the development of our next generation ... Develop software for medical device within a well-established robotics framework. * Driver ...

Clarapath

Senior Embedded Software Engineer

Hawthorne, NY · On-site

$130 - $170/hr

Senior Embedded Software Engineer LOCATION: Hawthorne, NY (on-site) TYPE : Full time, regular ... We are looking for a team player who views medical device development as a competitive advantage.

Intelas

Medical Device Integration Analyst

New York, NY · On-site

$75K - $85K/yr

Collaborating between biomedical engineering department, IT teams, application owners, and clinical ... Apply patches, software updates, and other device configurations as assigned * Assure compliance ...

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Contract Medical Device Software Engineer information

What is a contract medical device software engineer?

A Contract Medical Device Software Engineer is a software professional who is hired on a temporary or project basis to design, develop, and test software used in medical devices. They typically work with manufacturers to ensure that the software meets regulatory standards, such as those set by the FDA or ISO. Responsibilities may include creating embedded software, documenting code, and collaborating with cross-functional teams to deliver safe and effective medical products. Their expertise is crucial for developing reliable software that supports patient safety and product compliance.

What are the key skills and qualifications needed to thrive as a contract medical device software engineer?

To thrive as a Contract Medical Device Software Engineer, you need a solid background in software development (C/C++/Python), embedded systems, and knowledge of medical device regulations such as IEC 62304, typically supported by a relevant engineering degree. Familiarity with development environments, version control (e.g., Git), and tools for requirements management and verification are essential, along with any certifications in medical device software or quality systems. Strong problem-solving skills, attention to detail, and effective communication are crucial for collaborating with cross-functional teams and ensuring regulatory compliance. These skills and qualifications are vital to deliver safe, compliant, and innovative software solutions efficiently in a highly regulated and dynamic industry.

What are some common challenges faced by contract medical device software engineers, and how can they be addressed?

Contract Medical Device Software Engineers often encounter the challenge of rapidly adapting to new projects, technologies, and regulatory requirements unique to each client. Working within strict timelines while ensuring compliance with FDA and ISO standards can be demanding. To address these challenges, it's important to have strong communication skills, maintain thorough documentation, and stay updated on industry regulations. Collaborating closely with cross-functional teams—including quality assurance, hardware engineers, and regulatory affairs—also helps ensure project success and smooth integration into existing workflows.

What is the difference between Contract Medical Device Software Engineer vs Medical Device Software Developer?

AspectContract Medical Device Software EngineerMedical Device Software Developer
CredentialsTypically requires a degree in software engineering, biomedical engineering, or related field; certifications like ISO 13485 or FDA compliance knowledge are commonSimilar educational background; often holds certifications in medical device regulations or quality standards
Work EnvironmentContract roles in medical device companies, often project-based, with focus on compliance and validationFull-time or freelance positions within medical device firms, focusing on software development and testing
Industry UsageCommonly hired for specific projects requiring regulatory compliance and validation expertiseInvolved in ongoing software development, maintenance, and updates for medical devices

While both roles require technical expertise in medical device software, Contract Medical Device Software Engineers typically work on short-term projects with a focus on compliance and validation, whereas Medical Device Software Developers are involved in continuous software development and maintenance within the industry.

What are the most commonly searched types of Medical Device Software Engineer jobs in New York?

The most popular types of Medical Device Software Engineer jobs in New York are:

What cities in New York are hiring for Contract Medical Device Software Engineer jobs?

Cities in New York with the most Contract Medical Device Software Engineer job openings:

Contract Medical Device Software Engineer jobs near you

Design Software Quality Consultant (Medical Devices)

Piscataway, NJ • Remote

Stark Pharma Solutions Inc
See more jobs at Stark Pharma Solutions Incexternal

Contractor

Re-posted 25 days ago

Job description

Hi,

My name is Karthik Mutyala, from Stark Pharma Solutions Inc, we are hiring talents for our client. I am working on Design Software Quality position right now. Please send me your updated resume if you have relevant experience and interested in this position. The detailed job description is as follows

Role: Design Software Quality Consultant (Medical Devices)

Location: REMOTE
Duration: Long Term
 

Position Overview

We are seeking an experienced Design Software Quality Consultant to support post-acquisition integration activities for a medical device product portfolio. This role will focus on ensuring software design quality, regulatory compliance, and successful integration of acquired products into the client's quality management system.

The ideal candidate will have deep expertise in Software Design Quality, Model-Based Systems Engineering (MBSE), and medical device software compliance, with experience supporting new product development in regulated environments.

Key Responsibilities

  • Review and assess Design History Files (DHFs) and product development documentation for acquired medical device products.
  • Support software design quality activities during post-acquisition product integration.
  • Ensure compliance with internal quality standards and global regulatory requirements.
  • Lead Model-Based Systems Engineering (MBSE) activities for software-enabled medical devices.
  • Review software engineering deliverables to ensure compliance with design controls and quality requirements.
  • Partner with cross-functional teams including R&D, Software Engineering, Quality, and Regulatory Affairs.
  • Support risk management, usability engineering, and software lifecycle compliance activities.

Required Qualifications

  • 10+ years of Software Quality Engineering experience in the medical device industry.
  • Strong experience with Software Design Quality and Design Controls.
  • Hands-on experience with Model-Based Systems Engineering (MBSE).
  • Experience supporting software quality for new product development or medical device integration/remediation projects.
  • Knowledge of IEC 62304, IEC 60601, ISO 14971, and medical device software regulations.
  • Experience with Software as a Medical Device (SaMD).
  • Strong understanding of software verification, validation, and compliance within regulated environments.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.  

Please follow Stark Pharma Solutions on LinkedIn for the latest job updates: https://www.linkedin.com/company/99455976/

Thank you,

Karthik Mutyala

Recruiting Manager

Stark Pharma Solutions Inc

Email: karthik@starkpharma.com

15 Corporate Place S, Suite 350,

Piscataway, New Jersey 08854

www.starkpharma.com