Talent Finders, LLC ยท 4 weeks ago
Senior Product Development Engineer--Medical Device
Portland, Oregon Metropolitan Area
Full-time
Onsite
Senior Level
5+ years expTalent Finders, LLC is one of the Pacific Northwest's fastest growing Medical Device companies seeking an experienced Product Development Engineer to join their collaborative Development Team. The role involves developing systems and methodologies for medical devices, transforming concepts into prototypes, and leading design and development projects to meet customer needs.
Staffing & Recruiting
Hiring Manager
Dave Henry
Responsibilities
Plan, conduct, and manage design and development projects for medical devices in support of the company's strategic plan
Leads the development of new patient specific products
Maintain productive and respectful dialogue with customers to determine product requirements and ensure customer needs are met
Determines project schedule and strategy by studying project plan, specifications, calculating and risks, calculating time requirements, and sequencing project elements
Completes technical studies and prepares cost estimates
Manage compliance, quality control, and quality assurance standards and specifications
Mentor, lead and support other members of the engineering staff
Engage outside contracting services in support of project needs, i.e., analytical laboratories, consultants, material suppliers and equipment suppliers. Build effective relationships with these resources to meet delivery and budgetary goals
Research and understand device functionality, device patents, and clinical use
Design and develop products in full compliance with the internal Medical Design Control requirements per SOP820.030, and maintain design files for company products, including testing, testing reports, verification, validation, design files, and design reviews
Communicate with senior management to remove barriers/obstacles that could impair the projects timeline and/or overall success. Escalate barriers/obstacles to the appropriate leader to keep the project on track, on time, and within budget. Control costs by approving expenditure and seeking authorizations from the upper management as needed
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
Qualification
Required
Bachelor's degree in Mechanical, Materials Science, Chemical, Electrical or Biomedical engineering or equivalent work experience
4-10 years of experience working with medical devices; development, reprocessing and/or manufacturing
Preferred
Prior design experience in CAD using Solid Works
Experience with FDA 510(k) process or other regulatory submissions
Experience in a LEAN Manufacturing/Production environment, GMP and/or New Product Development
Benefits
Excellent benefits
Fantastic culture
Company
Talent Finders, LLC
A niche recruiting firm focused on the west coast manufacturing market.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase