Provides engineering and design services to manufacturing and production engineering groups
Develops concepts, designs and details for machines, tools, fixtures, and products
Contributes to cross-functional multidisciplinary project teams (R&D, manufacturing, marketing, regulatory, etc.) in the design, development and manufacturing of breast implants, tissue expanders, and related products and processes to fulfill clinical needs within regulatory requirements
Supports bench and pilot scale up operations, including equipment assembly, medium preparation, in process sample analysis, and the operation of reactors
Participates in the scale up of and optimization of processes and technologies
Assists in performing downstream processing by preparing equipment, preparing and controlling standard operating procedures, batch records and other compliance documents
Provides technical support to purification operations in pilot plant, including equipment cleaning/setup/prep, buffer preparation, in process testing and so on
Supports and helps troubleshoot
Participates in the transfer and implementation of new processes and technologies into the pilot plant, commercial manufacturing and contract manufacturing
Provides input to the development process validation plan
May develop procedures and processes within broader protocols
Conducts research, analysis or processes within a larger R&D activity
May develop and implement standards for reporting and operations
Ensures completion of activities within compliance and on-time
May identify and implement process level efficiencies
Supports safety and environmental initiatives by testing equipment prior to starting production
Uses analytical/technical expertise to contribute to product development/testing
Ensures that project guidelines are followed, and processes are complete
May coordinate with outside vendors or regulatory officials
May oversee reporting or regulatory processes or parts of processes
May be responsible for project or process reporting and tracking
May provide limited oversight of more junior staff on initiatives and projects
Provide training of new employees on covered jobs, and answering job-related questions in one or more areas
May monitor budgets as part of process administration
Demonstrate independent understanding and application of core GMP fundamentals, including but not limited to: Data Integrity (DI), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDPs)
Responsible for communicating business related issues or opportunities to next management level

Requirements

Bachelor’s degree in mechanical or biomedical engineering or related field, or equivalent required
MS degree is preferred
At least 2-4 years related engineering experience required
Experience in design, development and commercialization of Class I-II medical devices is preferred
Experience with mechanical testing and/or laboratory test method development is preferred
Skills and experience to develop appropriate protocols for conducting analysis
Specialized knowledge level, with sufficient experience and skill in techniques to independently determine how to set up and execute complex analysis
Requires understanding and application of a theoretical or scientific discipline – including the underlying principles involved
Applies standard practices and techniques in specific situations, adjusts and correlates data, and follows operations through a series of detailed steps and processes
Experience with polymer-based manufacturing and/or device design preferred
Working knowledge of basic statistics is required
Working knowledge of Design Control preferred
Designing with 3D CAD tools, including SolidWorks and rapid prototyping, including hands-on manual prototyping, SLA and FDM is desired
Proficiency with MS Office required.

Benefits

medical
dental
vision
life insurance
short- and long-term disability
business accident insurance
group legal insurance
consolidated retirement plan (pension)
savings plan (401(k))
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave – 10 days
Volunteer Leave – 4 days
Military Spouse Time-Off – 80 hours

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

mechanical engineeringbiomedical engineeringdesign developmentcommercialization of medical devicesmechanical testinglaboratory test method developmentprotocol developmentpolymer-based manufacturingbasic statisticsDesign Control

Soft skills

cross-functional collaborationproblem-solvingcommunicationtrainingproject managementindependent understandingattention to detailtime managementprocess optimizationcompliance adherence

Certifications

Bachelor’s degree in mechanical engineeringBachelor’s degree in biomedical engineeringMS degree in related field