200 W. Mercer Street Seattle, WA 98119 US
Position Description: Protingent Staffing has an exciting Direct Hire Manufacturing Engineer opportunity with our client in Seattle, Washington.
- Ability to lead a diverse team of cross-functional engineers and support personnel to successfully complete manufacturing outsourcing and Lean projects in a timely manner.
- Experienced project management and design control / stage gate development processes.
- Executes diverse engineering tasks related to the development of medical devices: from concept and development through commercialization.
- Leads the generation of concepts and principles and investigates their feasibility for current and future products. Provides conceptual modules and renderings which depict designs and alternatives and exhibit a high degree of creativity, functional simplicity and overall design excellence. Ensures designs are cost effective and meet customer requirements.
- Applies Design for Manufacturability (DFM) and Design for Assembly (DFA) techniques on both new and existing products to produce optimal design and manufacturing solutions.
- Provides specification analysis, component selection and product structure organization.
- Performs machine & system design, troubleshooting, root cause analysis, and mechatronic test fixtures for manufacturing.
- Maintains a professional, cooperative relationship with KOL’s, the customer and internal disciplines in order to provide superior levels of technical service.
- Actively manages intercompany resources and outside vendors in support of prototype fabrication, assembly, and validation testing.
- Partners with quality and operations to transition component and device designs to suppliers and contract manufacturers.
- Develops test methods to evaluate product performance.
- Incorporates Human Factors and User Interface elements into product designs. Conduct usability studies as appropriate.
- Generates requirement and specifications documents, test protocols and reports. Establishes inspection criteria.
- Defines, develops, and documents system and subsystem-level requirements and their corresponding evaluation procedures.
- Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Provides excellent communication of technical and program level issues as they arise to support the needs of the entire product development team.
- Supports multidisciplinary project activities. Collaborates with other team members (manufacturing, electrical, software, mechanical, clinical, quality) to solve complex, system level design challenges.
- Works within design controls, compliance testing, CE, ISO, FDA and other regulatory requirements.
- BS in Mechanical Engineering, Biomedical Engineering or related field.
- Minimum ten years of engineering experience, including leadership experience.
- Hands on knowledge/experience with disposable medical device designs.
- Up to 50% travel, national and international to support suppliers and CMs.
- Experience with design for assembly-automation is desirable.
- Skilled at managing projects in an engineering lead capacity. Motivates others and drives projects forward. Certification in Project Management (preferred)
- In-depth knowledge and experience designing parts for injection molding.
- Familiarity with a variety of prototyping processes.
- 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 the regulated environment.
- Knowledgeable of statistical methods.
- Experience utilizing external test laboratories and analysis services a plus.
- Leadership skills and proficient in project management techniques and processes
- Maintaining and strengthening relationships and developing a positive team culture.
- Ability to analyze and provide simple solutions to challenging situations
- Collaborate with company leaders and provide immediate feedback to team members
- Align project team towards company objectives and implement change as required.
- Self-sufficient, ability to execute complex pieces of work in a team environment.
- Technology role model, group oversite, proactively improving team(s) effectiveness.
- Direct Hire
- Salary Range: $90-130k/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.