Medical Device Development Jobs in Seattle, WA (NOW HIRING)

Principal Mechanical Engineer Aesthetic Medical Device (Bothell, WA)
Job Location: Bothell, Washington, USA
Job Requisition ID: 14590
Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it-where your skills and values drive our collective progress and impact.
The Principal Mechanical Engineer is responsible for leading the mechanical design of complex mechanical systems, designing hardware that satisfies system requirements, providing necessary design documentation, including detailed parts and assembly drawings to support the development, manufacture, and test of medical devices in the aesthetic space. The applicant must be a hands-on self-starter, who can work collaboratively with a multi-disciplinary product development team in accordance with the standards IEC 14971, IEC 60601, IEC 62366, and ISO 13485.
Principal Responsibilities and Duties:
Note: The following is meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.
• Provide technical leadership with mechanical design and analysis of subassemblies and systems through all phases of development and manufacturing.
• Work closely with other departments to ensure projects conform to all regulatory and quality requirements
• Create part and assembly models, detailed drawings, and associated parts lists, in accordance with AMSE Y14.5 drawing standards.
• Conduct / analyze tests with technical staff, cross functional team members, external partners, and potential users.
• Provide input and feedback for system requirements, cost estimates, project schedules, and DFMEA's.
• As required, develop and execute component hardware reliability and verification tests, along with accelerated life and stress tests.
• Communicate detailed technical specifications with worldwide suppliers of materials, parts, and equipment.
• Write engineering change orders to improve designs and address problems using Agile Product Life Cycle Management system.
• Familiarity with the requirements management process and willingness to use a requirements management tool
• Support the product transition to manufacturing, including manufacturing assembly and test fixtures along with assistance with initial builds
• Provide troubleshooting during production for new and mature products on an as needed basis.
Qualifications:
• BS or MS in Engineering or related discipline with at least 10 years of experience in the hands-on mechanical design and development.
• Demonstrated experience in leading / mentoring engineering professionals in a product development environment.
• Knowledge of various adhesive applications and bonding techniques commonly used in mechanical designs for the medical device industry.
• High proficiency using CREO and Windchill for mechanical design and documentation.
• Competency with GD&T to achieve high precision results in the design process.
• Good understanding of machining and/or other fabrication methods.
• Experience with injection molding processes
• Capable and self-sufficient in building and testing physical assemblies.
• Proficiency with finite element analysis (FEA) method, COMSOL preferred, for stress analysis, modal analysis, and heat transfer analysis.
• Strong team collaboration and communication skills and demonstrated ability to synthesize input from various cross-functional subject matter experts.
• Driven to get the job done in the face of obstacles and time constraints, and a willingness to jump in wherever needed.
• Demonstrated ability to multi-task.
Safety
Solta Medical is committed to the health and safety of our employees. We expect that all employees will perform their responsibilities while maintaining a safe, cooperative, and productive work environment, thus ensuring the health and safety of themselves and others.
The range of starting base pay for this role is $123K-$170K. Actual starting pay will be based on a wide range of factors including, but not limited to, relevant skills, experience, qualifications, education and location. In addition to base pay, this position is eligible for participation in either (i) our annual bonus program or (ii) a sales incentive plan.
Benefits package includes a comprehensive Medical (includes Prescription Drug), Dental, Vision, Flexible Spending Accounts, 401(k) with matching company contribution, discretionary time off, paid sick time, stock purchase plan, tuition reimbursement, parental leave, short-term and long-term disability, life insurance, accidental death & dismemberment insurance, paid holidays, employee referral bonuses and employee discounts.
We are an Equal Opportunity Employer. EOE Disability/Veteran. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.