200 W. Mercer Street Seattle, WA 98119 US
Position Description: Protingent Staffing has an exciting direct hire Principal Engineer opportunity with our client in Seattle, Washington.
- Company role model, strengthening relationships and developing a positive team culture.
- Planning and engineering strategies to achieve company objectives
- Experienced with upstream research, concept design, development and testing new products
- Defining department goals and developing execution plans
- Creating and managing engineering budgets
- Define and lead company-wide projects across multiple groups / teams.
- Oversee a diverse team of cross-functional engineers and support personnel to successfully complete projects in a timely manner.
- Provide technical expertise and guidance to junior engineers and team members
- Develop and maintain project timelines, budgets, and deliverables
- Develop and execute testing plans and protocols to validate and verify product performance
- Support manufacturing processes, including process validation and continuous improvement initiatives
- Participate in design reviews, technical discussions, and project status updates with senior management
- Stay up-to-date on industry trends and advancements in medical device technology
- Lead the design and development of medical devices, including defining user requirements, developing specifications, and creating detailed design documentation
- Ensure compliance with regulatory requirements, including FDA regulations and ISO standards
- Experienced project management and design control / stage gate development and ideation processes.
- Executes diverse engineering tasks related to the development of medical devices: from concept and development through commercialization
- Support projects in various capacities: i.e. as an individual contributor, as technical lead of a small team, or a subject-matter expert/consultant
- Incorporate Human Factors and User Interface elements into product designs. Conduct usability studies as appropriate
- Collaborate with marketing and clinical teams to identify product improvements and new product concepts
- Partners with quality and operations to transition component and device designs to suppliers and contract manufacturers
- Drive efforts for intellectual property strategy
- BS in Mechanical Engineering, Biomedical Engineering or related field. MS in Mechanical Engineering preferred.
- Minimum ten years of engineering experience, including medical device design.
- Experienced with upstream valuation and concept development.
- Experience leading successful project teams.
- In-depth knowledge and experience designing parts for injection molding
- Experience identifying and working with suppliers for a wide variety of medical device components.
- Working understanding of FDA Quality Systems Regulations and product development within that regulated environment
- Strong technical expertise in medical device development, including design controls, risk management, and regulatory compliance.
- Experience with medical device manufacturing processes and process validation
- Excellent project management skills, including the ability to manage multiple projects simultaneously.
- Strong problem-solving and analytical skills
- Highly proficient CAD user, with SolidWorks preferred.
- Familiarity with a variety of prototyping processes
- Experience utilizing external test laboratories and analysis services a plus.
- Self-motivated, ability to encourage and energize others.
- Open and effective communicator
- Job Type: Direct Hire
- Pay Rate Range: $150k-190k/year
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.
Meet Your Recruiter
I have worked in Technical staffing for over 17 years in the Pacific NW primarily, and Nationally. My specialty is finding candidates for contract, contract to hire and direct hire jobs in Technical & Engineering fields for some of the greatest Hardware & Software product development companies around. I listen to what you are looking for and will ensure your resume looks great. I am honest and communicative throughout the hiring process. I am passionate about putting our Veterans back to work, and helping underrepresented people get into STEM careers.