Bachelor's degree in engineering or equivalent work experience
5-6 years of direct R&D experience in the medical device industry, particularly with electromechanical devices
Preferred experience with durable medical capital equipment and single-use devices
Strong written and verbal communication skills, including technical writing and presentation abilities
Collaborative mindset with a proven ability to work effectively in teams
Robust engineering, design, and analysis skills, with experience from concept to commercialization
In-depth understanding of FDA Quality Systems Regulations and relevant standards (21CFR820, ISO 13485, 14971, 11607)
Proficient in quality tools and methodologies such as SPC, DOE, GR&R, FMEA, CAPA, and process validation.
Responsibilities
Provide quality and compliance input to project teams for key deliverables
Develop and maintain quality documentation ensuring regulatory compliance
Represent quality initiatives during design and phase reviews
Lead and support quality disciplines and decision-making processes
Document product standards in specifications and conduct quarterly gap analyses
Teach and implement statistically valid sampling techniques and advanced statistical methods
Direct the implementation of acceptance activities and inspections
Apply systematic problem-solving methodologies to resolve quality issues
Support CAPA/NCRs/Complaints and assist with special projects as needed.
Benefits
Opportunity to work on innovative medical devices
Collaborative team environment
Professional development and training opportunities
Engagement in quality initiatives and compliance efforts
Exposure to various stages of product development from concept to commercialization.
Full Job Description
Description
What You'll Do
Provide quality and compliance input to project teams for decisions and deliverables (e.g., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Review, Design V&V, Usability Testing, Process Validation, and Labeling).
Develop quality documentation such as quality plans, standard operating procedures, and inspection procedures. Ensure regulatory, FDA, and ISO compliance in all areas of responsibilities.
Represent Quality initiatives and compliance when participating and Design and Phase reviews
Serve as an effective leader and team member in supporting quality disciplines, decisions, and practices.
Ensure that required standards for products are documented in the product requirements (PR) specification and ensure compliance by performing quarterly gap analysis and reviewing applicable verification documentation.
Ensure the use of statistically valid sampling techniques and teach others on the use of these and other advanced statistical techniques such as DOE and ANOVA evaluations.
Provide direction and lead the implementation of Acceptance Activities, First Article Inspections, In-Process Inspections, Sampling Plans, product/component testing, inspections, and acceptance criteria.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Provide support for CAPA/NCRs/Complaints
Assists with special projects as needed.
What We Look For
Bachelor's degree in engineering or equivalent work experience
Minimum of 5-6 years' direct R&D experience in medical device industry working with electromechanical devices
Experience with durable medical capital equipment in addition to single-use devices is preferred
Excellent written and verbal communication skills with good presentation and technical writing skills
Collaborative attitude with the ability to work well in a team environment
Strong engineering, design, and analysis skills along with experience with medical devices from concept to commercialization
Understanding of FDA Quality Systems Regulations
Demonstrated use of quality tools and methodologies including SPC, DOE, GR&R, FMEA, CAPA, and process validation (IQ, OQ/PQ).
Must have a good understanding of FDA 21CFR820, ISO 13485, 14971, and 11607 standards.
