Software Design Control Engineer

Maxonic Inc.; Sunnyvale (CA); On-site; USD 150,000 - 200,000; Full time

Job summary

An established industry player is seeking a talented Software Design Control Engineer to enhance product quality through effective design control and risk management. This role involves developing technical documentation and collaborating with cross-functional teams to ensure compliance with regulatory standards. The ideal candidate will possess strong analytical skills and a commitment to delivering robust software solutions. Join a forward-thinking company that values innovation and quality, where your contributions will directly impact the success of cutting-edge projects.

Qualifications

• 5+ years of industry experience in software design control.
• Strong writing and analytical skills for technical documentation.

Responsibilities

• Develop and maintain design control infrastructure and documentation.
• Collaborate with various teams to resolve design gaps and risks.

Skills

Design Controls

Technical Documentation

Risk Management

Analytical Skills

Communication Skills

Education

BS in Engineering

Tools

MKS

Polarion

Job description

Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Software Design Control Engineer.

Job Description:

Job Title: Software Design Control Engineer

Job Location: Sunnyvale, CA

Rate: $70/hr on W2, Based on experience

Responsibilities:

Primary Function of Position:

The individual in this role will leverage their expertise in design controls to evaluate the impact of design changes on requirements, specifications, and risks. The ideal candidate will be adept at producing technical documentation to meet the demands of software releases and regulatory submissions, thereby enhancing throughput and addressing trace gaps early in the development phase.

The successful candidate will possess both the technical acumen to comprehend software designs and a strong commitment to risk management and design control deliverables, ensuring the delivery of robust products to the market. A sense of shared responsibility and reward, along with a dedication to high product quality, is essential for this role.

Roles and Responsibilities:

As a Software Design Control Engineer, you will be responsible for delivering technical documentation to support projects with minimal impact on resources while ensuring operational effectiveness. You will work within the Multiport software team and collaborate closely with Design and Product Engineering, Quality, and Document Control teams. Key responsibilities include:

Developing, executing, maintaining, and supporting design control infrastructure (risks/FMEAs, requirements, etc.).

Generating trace reports, identifying, and resolving gaps through collaboration with various departments.

Informing design decisions based on documented product risk and design control strategy.

Supporting the Multiport team in creating trace, requirement, test protocol/report, TLTR, Known Anomaly List documents for regulatory submissions and software releases.

Experience/Skill/Job Requirements:

BS degree in engineering discipline, or equivalent

5+ years industry experience

Familiarity with design controls risks, trace reports, design controls

Strong writing and grammar skills in areas of content development and writing style. Analytical ability to swiftly grasp and effectively communicate complex technical engineering concepts.

Excellent written and verbal communication skills with a proven ability to present information in a clear and concise manner to various technical, business stakeholder, and leadership audiences

Preferred Qualifications and Skills:

While the candidate is expected to have some of the following skills, a strong propensity for learning and the ability to synthesize new information effectively will be highly valued:

Experience creating or modifying risks, trace reports, functional requirements, etc.

Knowledge of medical device regulations, both US and OUS (e.g., FDA regulations, MDR, China PTR, etc.).

Experience working with design control software (MKS, Polarion, etc.).

Strong organizational skills and the ability to manage deliverables under tight deadlines, set priorities, and manage time effectively.

Team player with the ability to interface with technical SMEs and business stakeholders across multiple disciplines to achieve the best outcomes.

Ability to quickly learn new tools, drive process improvement, and manage change.

Demonstrated ability to understand, resolve, and communicate technical and business issues.

Organized and detail-oriented, with a high level of integrity and reliability.

Excellent analytical and problem-solving skills with attention to detail; mission-critical production support experience.

Solid foundation in system engineering principles such as requirements definition, system integration, formal verification, and validation methods.

About Maxonic:

Since 2002 Maxonic has been at the forefront of connecting candidate strengths to client challenges. Our award winning, dedicated team of recruiting professionals are specialized by technology, are great listeners, and will seek to find a position that meets the long-term career needs of our candidates. We take pride in the over 10,000 candidates that we have placed, and the repeat business that we earn from our satisfied clients.

Interested in Applying?

Please apply with your most current resume. Feel free to contact Sagar Kainth ([e-mail] /[phone]) for more details.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Information Technology

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