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).

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, as opposed to practices (e.g. chemistry).
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, and group legal insurance.
Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and 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 developmentcommercializationmechanical testinglaboratory test method developmentprotocol developmentpolymer-based manufacturing3D CAD designbasic statistics

Soft skills

cross-functional collaborationproblem-solvingtechnical supporttrainingproject managementcommunicationindependent analysisattention to detailtime managementprocess optimization

Certifications

Bachelor's degreeMaster's degree (preferred)GMP certification