Remote Systems Design Engineer

Information technology Remote systems design engineer

REMOTE SYSTEMS DESIGN ENGINEER.

warsaw, indiana Posted 2 days ago Closes in 2 days Job details Summary Spherion $75,000 - $85,000 per year Temporary 8:00 AM - 5:00 PM Industry information technology (Computer and Mathematical Occupations) Reference number S_175106 We're seeking a System Design Engineer to assist with a high-priority integration initiative following a major acquisition. This is a fast-paced, high-impact role, where the primary mission is transferring complex systems into the existing enterprise ecosystem. This position is fully remote and operates as a 6-7 month contract with the potential for long-term extension or conversion to full-time based on performance and business needs.

What's In It For You:

Fully Remote Work:

Enjoy the flexibility of working from wherever you are most productive.

High-Impact Project:

Play a critical role in a major acquisition integration for a global orthopedic leader.

Technical Growth:

Gain experience navigating complex regulatory landscapes and working with sophisticated SaMD technology that will significantly enhance your professional resume.

Competitive Compensation:

Salary range of $75k-$85k/year

Responsibilities:

Act as the primary bridge between user requirements and technical solutions. Lead the refinement of technical documentation to ensure compliance with medical device regulations. ... Define design approaches and lead technical reviews, balancing usability with long-term sustainability. Execute hands-on Verification and Validation (V&V) by developing protocols and conducting manual and automated testing. Manage Remediation and Compliance efforts, with a heavy focus on maintaining the Design History File (DHF). Collaborate with Quality Assurance and Regulatory teams to address gaps and meet FDA and ISO standards.

Working hours:

8:00 AM - 5:00

PM Skills:

Standards:

Knowledge of

IEC 62366.

Availability:

Ability to work a schedule aligned with Mountain Time.

Mindset:

Ability to "hit the ground running" in a fast-paced, documentation-heavy environment.

Education:

Bachelors Experience:

4-7 years

Qualifications:

Experience:

Minimum of 5 years in medical device design, specifically with Software as a Medical Device (SaMD).

Education:

Bachelor???s degree in Engineering or Science (Biomedical Engineering is highly preferred).

Technical Proficiency:

Deep knowledge of Design Controls, DHF maintenance (traceability, design inputs/outputs), and risk analysis including uFMEA.

Standards:

Strong familiarity with

ISO 14971.

Tools:

Proficient in using Codebeamer or Jira for tracking and documentation. today! Send your resume to SpherionProfessionals-dl@spherion.com for immediate consideration! #PROFDIV Spherion has helped thousands of people just like you find work happiness! Our experienced staff will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temp-to-perm or direct hire opportunities, no one works harder for you than Spherion.

Equal Opportunity Employer:

Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At Spherion, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact Callcenter@spherion.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Spherion offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). Show more key responsibilities Act as the primary bridge between user requirements and technical solutions. Lead the refinement of technical documentation to ensure compliance with medical device regulations. Define design approaches and lead technical reviews, balancing usability with long-term sustainability. Execute hands-on Verification and Validation (V&V) by developing protocols and conducting manual and automated testing. Manage Remediation and Compliance efforts, with a heavy focus on maintaining the Design History File (DHF). Collaborate with Quality Assurance and Regulatory teams to address gaps and meet FDA and ISO standards. experience 4-7 years skills

Standards:

Knowledge of

IEC 62366.

Availability:

Ability to work a schedule aligned with Mountain Time.

Mindset:

Ability to "hit the ground running" in a fast-paced, documentation-heavy environment. qualifications

Experience:

Minimum of 5 years in medical device design, specifically with Software as a Medical Device (SaMD).

Education:

Bachelor???s degree in Engineering or Science (Biomedical Engineering is highly preferred).

Technical Proficiency:

Deep knowledge of Design Controls, DHF maintenance (traceability, design inputs/outputs), and risk analysis including uFMEA.

Standards:

Strong familiarity with

ISO 14971.

Tools:

Proficient in using Codebeamer or Jira for tracking and documentation. education Bachelors share this job. send via e-mail print it Get in touch. We are here to help you with your questions. EA Ewing, Ashly ashlyewing@spherion.com