Key skills
R&D in medical device industryElectromechanical devicesDurable medical capital equipmentMedical devices design and analysisFDA Quality Systems RegulationsStatistical Process Control (SPC)Design of Experiments (DOE)Gauge Repeatability and Reproducibility (GR&R)Failure Modes and Effects Analysis (FMEA)Corrective and Preventive Actions (CAPA)Process validation IQProcess validation OQProcess validation PQFDA 21CFR820ISO 13485ISO 14971ISO 11607RUsability TestingCommunication
About this role
ECI is a global leader in professional consulting services for the life sciences industry, seeking a Senior R&D Engineer to provide quality and compliance input for medical device projects. The role involves developing quality documentation, ensuring regulatory compliance, and leading quality initiatives within project teams.
Responsibilities:
- 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
Requirements:
- 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
- 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
- Experience with durable medical capital equipment in addition to single-use devices