Senior R&D Engineer - Medical Device #0132

About the role

This is an Onsite role in Massachusetts.

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.
• Affords assistance 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
• Experience with durable medical capital equipment in addition to single-use devices is preferred

Qualifications

• 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
• 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 Quality Systems Regulations, FDA 21CFR820, ISO 13485, 14971, and 11607 standards.

Skills

• Statistical tools and methodologies (SPC, DOE, GR&R, FMEA, CAPA, process validation)
• Quality systems regulations (FDA 21CFR820, ISO 13485, 14971, 11607)

Benefits

• ECI is an equal opportunity employer.

Pay

Negotiable based on experience and qualifications.

Schedule

Full-time, Onsite position in Massachusetts.