Engineer II

This is a fully remote position, open to applicants in California, +2 more states.

📋 Description

• You will oversee the product’s compliance with all safety, efficacy, and functionality standards through effective product lifecycle management.

• You will be in charge of creating and maintaining design documentation in alignment with quality procedures.

• Offering guidance on the design requirements and specifications for combination products and devices.

• Leading product testing strategies and execution to validate product safety, performance, and effectiveness.

• Manage the Design History Files for combination products and devices.

• Analyze data to support design acceptance, performance capabilities, and failure analysis.

• Develop and drive test protocols, methodologies, and reporting.

• Facilitate the transfer of technical information to manufacturing sites, assisting in manufacturing scale-up and product launches.

• Utilize fundamental engineering skills and practices to gather user requirements and convert them into documentation.

• Engage with suppliers and development partners regarding specifications and quality standards.

• Provide authorship and expert technical guidance for regulatory submissions.

• Manage project scope, timelines, and budget effectively.

• Maintain and support quality records, change records, and any deviations.

• Assist in device design complaint investigations and monitoring to ensure prompt resolution and ongoing improvement.

• Collaborate with Process Development and external partners as a technical authority.

⛳️ Requirements

• Master’s degree.

• Alternatively, a Bachelor’s degree with 2 years of experience in Engineering and/or Operations.

• Or an Associate’s degree with 6 years of experience in Engineering and/or Operations.

• Or a High school diploma / GED with 8 years of experience in Engineering and/or Operations.

• A Bachelor's degree in engineering or a science-related field along with 5+ years of relevant work experience in an operations/manufacturing environment.

• Experience within the medical device, pharmaceutical, or a similar regulated industry.

• A background in the development and commercialization of medical devices, with knowledge of manufacturing processes.

• Familiarity with the following standards and regulations: Quality System Regulation – 21CFR820.

• Quality Management System for medical device/component manufacturers - ISO 13485.

• Risk Management for Medical Devices – ISO 14971.

• Strong communication and technical writing skills.

🏝️ Benefits

• A comprehensive employee benefits package, which includes a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models where feasible.