Job Description
Job Description
Job Description
Job Title: Software Design Control Engineer
Position Description : Protingent Staffing has an exciting contract opportunity for Software Design Control Engineer with our client located in Sunnyvale, CA.
Job Description: - 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.
Job Responsibilities: - 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.
- 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.
Job Qualifications: - BS degree in engineering discipline, or equivalent
- 5+ years industry experience
- Medical device 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
- Ability to read and interpret detailed mechanical drawings containing GD&T to be able to communicate technical information regarding manufacturing and inspection.
Preferred Job Qualifications: - 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.
Job Details: - Job Type: Contract
- Pay Range: $60 - $65 an hour.
- Location: Sunnyvale, CA (Onsite).
Benefits Package: Protingent offers competitive salaries, insurance plan options (HDHP plan or POS plan), education/certification reimbursement, pre-tax commuter benefits, Paid Time Off (PTO), and an administered 401k plan.
About Protingent: Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom, and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding, and exciting work opportunities for our candidates.
Seniority level
Seniority level
Mid-Senior level
Employment type
Job function
Job function
Engineering and Information Technology
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Full time, Contract work, Summer work,