[Remote] reputed company Engineer II - Medical Device #0959

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 reputed company Engineer II 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 reputed company 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 3-5 years' reputed company R&D experience in medical device industry working with electromechanical and cardiac rhythm 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

reputed company