System Engineer

Remote • Posted 5 hours ago • Updated 5 hours ago
Contract Corp To Corp
Contract W2
12 Months
Remote
$65 - $68.99/hr
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Job Details

Skills

  • SYSTEM ENGINEER

Summary

At a Glance:
Are you ready to build your career by joining a certified technology solutions and compliance consulting services company?  If so our client is hiring a System Engineer.
 
Position Type:
  • Contract
  • Remote 
Responsibilities:
  • Design Controls: Lead efforts to develop and implement robust design control processes for new and existing products, ensuring compliance with FDA regulations (21 CFR 820), ISO 13485, and other relevant industry standards.
  • Traceability: Establish and maintain traceability throughout the design and development phases, ensuring that user needs, design inputs, and verification requirements are fully traced and documented.
  • User Needs to Design Validation: Work cross-functionally to trace user needs to design validation, ensuring that final products meet both the defined requirements and user expectations. This includes the development of comprehensive Design History Files (DHF) and validation documentation.
  • Design Verification & Validation (V&V): Collaborate with teams to ensure that all products undergo thorough design verification and design validation processes, providing evidence that the product meets the necessary specifications.
  • Cross-Functional Collaboration: Work closely with other engineering disciplines, such as hardware, software, and quality teams, to ensure a seamless integration of design controls and traceability throughout the product lifecycle.
  • Documentation and Reporting: Prepare and maintain detailed documentation for design control processes, ensuring all deliverables are compliant with internal and regulatory standards. Provide updates to leadership and stakeholders on project status, risks, and timelines.
  • Continuous Improvement: Identify areas for process improvements in design control and traceability methods, and implement changes that enhance the efficiency and effectiveness of product development.
Required Qualifications:
  • Experience: 5-8 years of experience in system engineering within a regulated environment, preferably in medical devices or other highly regulated industries.
  • Design Controls: Strong experience in implementing and managing design controls processes, including traceability, user needs, and design verification/validation.
  • Traceability: Proven ability to ensure full traceability from user needs to design validation and manage product documentation accordingly.
  • Regulatory Knowledge: In-depth knowledge of FDA regulations (21 CFR 820), ISO 13485, and other applicable standards for medical devices.
  • Collaboration: Strong communication and interpersonal skills, with experience working effectively in cross-functional teams.
  • Strong verbal and written communication in English
  • Preferred Qualifications:
    • Risk Management: Experience with risk management processes, including risk analysis, risk assessment, and mitigation strategies (e.g., ISO 14971).
    • V&V Experience: Familiarity with verification and validation techniques and methodologies for ensuring that product designs meet both functional and regulatory requirements.
    • Software and Tools: Experience with requirements management tools, traceability software, and common V&V tools.
  • ​​​​​​​Personal Attributes:
    • Strong analytical and problem-solving skills
    • Ability to manage and prioritize multiple tasks in a fast-paced environment
    • Detail-oriented with a commitment to accuracy
    • Proactive and able to work independently or as part of a team
Get in Touch:
We want to hear from you! If you think you’d be a good match, submit your resume and reach out to Vaibhav at to learn more.

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Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: mic
  • Position Id: 26-00894
  • Posted 5 hours ago

Company Info

About Hired by Matrix, Inc.

Hired by Matrix is a leading staffing organization providing exceptional contingent and permanent staffing solutions to clients across the United States.  At Hired by Matrix, we believe in the human touch and start every partnership with an in-depth conversation. By talking with our clients about their hiring needs and listening to job seekers describe their career goals, we build an understanding of what they are looking for and work hard to make it happen.  Further, as a proud member of the Women’s Business Enterprise National Council (WBENC), we strive for excellence in diversity and inclusion. 

Our staffing services encompass a wide range of industries and professions:

·         Travel Nursing: We excel in connecting healthcare facilities with highly skills Travel Registered Nurses for bedside care on short-term engagements as well placing professional allied health staff. 

·         Information Technologies: We provide businesses with proficient IT Professionals who possess expertise in various technologies and programming languages.

·         Engineering: We have a team specialized in recruiting talented engineers for diverse industries such as civil, mechanical, electrical, manufacturing and more. 

·         Human Resources: Our comprehensive HR staffing solutions help companies find to HR professional with extensive knowledge in recruitment, employee relations and HR Management. 

·         Life Science: We assist companies in the pharmaceutical, biotechnology, and medical device sectors by sourcing scientific and research professionals with specialized expertise

·         Finance & Accounting: We provide finance and accounting professionals to organizations, including CFO’s, Accountants, financial analysts, and more. 

·         Administrative & Clerical: We supply administrative support staff, including receptionists, office managers, administrative assistants, and clerical personnel. 

We are proud of the company we keep and are honored to have a strong array of clients who put their faith in us to help their business flourish.  Our wide range of clients includes several of the top fortune 100 companies.  Further, to support a balance between work and home life, Hired by Matrix has elected to be a 100% distributed work environment.  This approach allows us to support our clients in the way they work, when they work. 

Why Hired by Matrix?

Extensive Industry experience: With years of experience, we possess in-depth knowledge and understanding of our specific staffing requirements and challenges across different industries.

Long Term Relationships: Exceptional relationships with multiple clients that expand over 2 decades.

Exceptional Talent Pool: Our vast network and comprehensive candidate database allows us to connect business with highly skilled professionals who meet their specific criteria and culture fit.

Quality screening: We conduct rigorous screening and assessment processes to ensure our candidates possess the necessary qualifications, skills, and experience required by our clients.

Customized Solutions: We tailor our staffing solutions to meet the unique needs and preferences of each client, providing flexible and scalable options that align with their organizational goals. 

Dedicated Customer Support: Our Dedicated team is committed to delivering excellent customer service, providing ongoing support through our Consultant Appreciation Program which provides guidance throughout the onboarding process and beyond. 

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