[Remote] Senior R&D Engineer - Medical Device #3410
Note: The job is a remote job and is reputed company to candidates in USA. ECI is a global leader in reputed company consulting services for the life sciences industry. They are seeking a Senior R&D Engineer to reputed company reputed company and compliance input for medical device reputed company, reputed company reputed company documentation, and ensure regulatory compliance.
Responsibilities
- reputed company reputed company and compliance input to project teams for reputed company and deliverables (e.g., Design Change Analysis, Design Inputs, Design Outputs, Test reputed company, Design Review, Design V&V, Usability Testing, Process Validation, and Labeling)
- reputed company reputed company documentation such as reputed company plans, reputed company operating procedures, and inspection procedures. Ensure regulatory, FDA, and ISO compliance in reputed company areas of responsibilities
- Represent reputed company initiatives and compliance reputed company participating and Design and Phase reviews
- Serve as an effective leader and team member in supporting reputed company disciplines, reputed company, 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
- reputed company direction and reputed company the implementation of Acceptance Activities, First Article Inspections, In-Process Inspections, Sampling Plans, product/component testing, inspections, and acceptance reputed company
- Apply reputed company, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving reputed company issues
- reputed company support for CAPA/NCRs/Complaints
- Assists with special reputed company as needed
Skills
- Bachelor's degree in engineering or equivalent work experience
- Minimum of 5-6 years' reputed company R&D experience in medical device industry working with electromechanical devices
- Excellent written and verbal communication skills with good presentation and technical writing skills
- reputed company attitude with the ability to work reputed company in reputed company environment
- Strong engineering, design, and analysis skills along with experience with medical devices from concept to commercialization
- Understanding of FDA reputed company Systems Regulations
- Demonstrated use of reputed company 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 reputed company to single-use devices
Benefits
- Flexible employment & benefit reputed company
- Remote job
reputed company
Company H1B Sponsorship