The Senior Design Quality Engineer will partner with the R&D team to support the development and advancement of RefleXion’s novel biology-guided radiotherapy (BgRT) system by assisting with the development of requirements, specification, risk analysis, test plans, and test reports along with the implementation of design processes that are compliant to applicable standards and regulations. This position will represent Quality Assurance for hardware development and support sustaining engineering to drive improvements for design procedures with respect to hardware and equipment.
- Provides guidance, support and training for RefleXion team members to ensure a solid understanding of and compliance to applicable regulations and standards and RefleXion’s quality processes with a focus on Risk Management and Design Controls.
- Performs work that involves conventional engineering practices and may also include a variety of complex features such as resolving conflicting design requirements and unsuitability of standard materials.
- Designs, develops, refines, and validates test methods and inspection procedures. Guides/authors design verification and design validation protocols and reports.
- Develops, refines, and validates traceability of risk analysis, hazard analysis, failure modes, and risk controls to design requirements/specifications.
- Participates in design verification and validation planning and execution utilizing a risk-based approach sufficient to support a 510(k) submission and clearance, as well as international submissions (e.g., EU).
- Provides technical guidance in statistical analysis techniques, experimental design and other engineering areas of expertise.
- Establishes and maintains relationships to provide effective representation of Quality Assurance to internal and external customers as well as suppliers.
- Takes an active role as Subject Matter Expert (SME) during audits and investigations related to design aspects to ensure optimal outcomes.
- Interfaces with all internal departments to proactively identify potential issues and develop solutions to minimize or prevent adverse effects on project plans.
- Drives failure investigations and corrective actions necessary to assure conformity to quality specifications through the support of NCR/CAPA/SCAR activities.
- Supports software quality team and interfaces with software quality to ensure consistency in approach and design.
- Performs other relevant tasks as assigned.
- Bachelor of Science degree in Engineering discipline or related field required.
- 5 to 8 years in the Medical Device industry required (design related)
- Experience in a capital equipment/software product environment required
- Strong and effective communication skills, both written and oral, and must be highly computer literate.
- Working knowledge and experience in developing and maintaining medical devices in conformance with FDA Quality System Regulation, ISO 13485, 14971, 62304, 62366 and IEC 60601 requirements.
- Knowledge of analytical tools and methods related to design, development, and manufacturing, including statistics, DOE, and the use of computer/software packages.
- Must possess a high sense of urgency and initiative with a practical approach to daily challenges.
- Must be able to effectively manage multiple priorities across many disciplines in a fast paced and dynamic environment.
- Master’s degree preferred.
- Experience in areas such as: design of analog or digital circuits, signal processing, micro power sources, electromechanical devices, computational simulation and modeling, integration of subsystems, fabrication of prototypes, and/or conductance of qualification tests preferred.
- Experience with Arena PLM, Helix ALM, SolidWorks, Mentor Graphics, PADS, Minitab and MATLAB preferred
- CQA/CQE certification or lead auditor certification a
- Lean and/or Six Sigma experience a preferred. Yellow, Green or Black Belt certification a plus.
Company Benefits and Perks – What you will love about us!
All positions at RefleXion are eligible to receive the same benefits, listed here. We also want to highlight the following perks that add to our collaborative and team-work company culture. As we continue to grow as a company, we strive to have these benefits and perks grow with us – we are so excited for what is in store!
- The opportunity to work with a passionate, driven team in a pre-IPO start-up environment.
- Competitive compensation and stock option package
- Three (3) weeks PTO to start.
- Medical (both HMO and PPO options), Dental and Vision
- Health Savings Account (HSA), Flexible Spending Account (FSA), Dependent Care Flexible Spending Account (DCFSA)
- Employee Assistance Program (EAP)
- Employer paid Life Insurance.
- RefleXion Benefit Hub – for company exclusive discounts and deals on a variety of sites and items.
- Free daily on-site lunches
- Kitchens filled with a variety of healthy and delicious snacks and drinks – including espresso and soda machines!
- Company culture building events such as Coffee Chats with the Executives, Friday Afternoon Ice Cream Socials, and monthly Book Club
- On-site mobile car wash services weekly
- Electric car charging stations on site