15 Jan
Minnesota,
Plymouth
, 55441
Plymouth
USA
Vacancy expired!
Responsibilities/Duties:Perform Design Assurance engineering work requiring full competency in software and/or embedded software engineering. Plans and conducts design assurance activities related to software lifecycle processes compliant with EN/IEC 62304; works closely with product development engineering to establish new approaches to problems as encountered. Actively participates in software development planning to ensure design verification and validation activities conform to established product requirements and sound testing principles. Routinely provides Design Assurance guidance and direction to engineers/technicians on the project assignment.Conducts Design Assurance engineering activities of significant scope or degree of difficulty (medium-large component/system/process associated with a medium to large project). Performs most assignments independently, with only general supervision/instruction as to expected results.- Reviews new product development and improvement project plans.
- Reviews product risk analyses, including cybersecurity risk analysis.
- Reviews engineering requirement specifications.
- Reviews product design documents.
- Reviews product test plans and results.
- Reviews product tracing (requirements to test, etc.)
- Reviews product change requests.
- Reviews product and process validation test plans.
- Reviews and reports on design history file.
Maintains communications within and outside of department in support of design assurance engineering activities, such as project management meetings, design reviews, etc. Actively participates in and contributes to the decision-making process. Interfaces with development, design, and manufacturing engineering areas to resolve quality and product issues. Generates periodic activity and project reports.In addition to assigned duties this position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including but not limited to FDA, Quality Systems Regulations, ISO 13485, ISO 14001, government occupational health and environmental regulations and statutes). Technical Knowledge and Skills:Bachelor's degree is required with 5-8 years' experience. Preferred in Software Engineering / Computer Engineering or equivalent; with seven to ten years' professional level experience within the medical, or a closely related industry, is required. Specific experience in design assurance desirable. (Alternately: Master's Degree with 4-6 years’ experience, or Ph.D. with 3-5 years.)Possesses and applies a comprehensive knowledge of software engineering, as well as competency in related specialty fields (electrical engineering, etc.). Knowledge is evidenced by breadth of experience, previous job progression, accomplishments and performance levels.- Demonstrated effective analytical and problem-solving skills to identify root causes and probable solutions quickly.
- Able to effectively utilize other resources when necessary to resolve issues, especially those outside of expertise.
- Excellent verbal communication skills and technical writing skills. Able to plan and conduct effective meetings and group presentations.
- Knowledge and skill in software engineering documentation procedures, development methods and project management, with the ability to rapidly master Clients Medical internal procedure and methods, such as Documentation System, ECOs, DVTs, etc.
- Depth of knowledge of applicable QSSOPs, regulations, and standards etc. with proven skill in integrating into software engineering discipline.
- In depth knowledge of ISO 13485, ISO 14971, 21 CFR 820 Design Controls, and EN/IEC 62304.
- Proven experience with documentation systems, requirements management and trace systems, testing and inspection procedures, validation and qualification expertise.
Abilities:Ability to work independently to perform required tasks.- Proven ability to handle multiple priorities, shifting focus quickly.
- Ability to work with individuals and teams in an effective and positive manner.
- Ability to coordinate and lead project team activities in an effective and efficient manner. Team members typically include diverse inter-department staff including Regulatory, Marketing, Purchasing, Operations, Design, QA, Production, etc. Ability to work with individuals and teams in an effective and positive manner.
- Demonstrated flexibility and resilience in the face of constraints, frustrations or adversity.
- Ability to coordinate and lead cross functional team projects as well as develop working schedules.
- Ability to provide basic on-the-job technical training to others in department; ability to clearly convey ideas and concepts.
Planning and Decision Making:Works under only general supervision, with direction given only in terms of broadly stated objectives and desired outcomes. Continuously reviews project team progress and evaluates results accordingly. Independently plans, schedules, conducts or coordinates detailed phases of the assigned project.- Direction is usually given in terms of goals or objectives taking several weeks or months to accomplish.
- Controls/constraints over this position include policies and procedures for software development and GMP requirements.
- This position is required to meet deadlines for completion of specified projects.
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