Senior Design Assurance Engineer

Our team is growing, and we are currently looking for a Senior Design Assurance Engineer to join our Quality Engineering team. The Senior Design Assurance Engineer will be responsible for providing quality support for New Product Introduction (NPI) projects, ensuring that all design and development processes comply with applicable regulations and standards. This role requires a deep understanding of design controls, risk management, and usability engineering within the medical device industry. This position works closely with cross-functional teams, including R&D, Regulatory Affairs, and Process Engineering, to ensure the successful launch of new products that meet the highest quality and safety standards.Impact Through InnovationEnsure the effectiveness of design controls activities for NPI projects, ensuring compliance with ISO 13485, MDSAP and other relevant regulatory requirements.Ensure risk management files are developed and maintained throughout the product lifecycle, identifying potential risks, and ensuring appropriate mitigation strategies are implemented.Provide usability engineering and human factor expertise to ensure user-friendly and safe medical devices.Collaborate with cross-functional teams to develop and execute quality plans for new products, leveraging clinical knowledge to guide device design and testing, and ensuring design verification, validation, and qualification activities are conducted as per established protocols and regulatory standards.Provide valuable quality input throughout the product development process and ensure compliance with applicable standards and regulations by thoroughly reviewing and approving design inputs, outputs, and Design History Files (DHF).Identify opportunities for process improvement within the design and development lifecycle, implementing best practices to enhance product quality and development efficiency.Apply data-driven problem-solving and statistical analysis to systematically identify and address quality issues for new product development, enhancing product reliability and safety.Champion a quality-first mindset that emphasizes patient safety and customer satisfaction throughout the NPI process.Provide training and mentorship to junior engineers and other team members on quality engineering principles, design controls, risk management, and usability.Required Skills:5+ years of relevant experience in the medical device industry.2+ years of experience with NPI processes or in a direct design assurance position.Knowledge of ISO 13485, ISO 14971, IEC 62366-1.Experience with design controls, design inputs and outputs, and risk mitigation activities.Excellent analytical and communication skills (both written and oral).Excellent organization and time management skills.Proficient in MS Office.Our Distinctive EdgeEffortless commute: say goodbye to commuting challenges/hassles with our complimentary shuttles and subsidized transit options, making your journey to work a breeze.Work-life integration: Embrace a well-balanced work-life rhythm through our hybrid model and flexible hours, empowering you to thrive both personally and professionally.Making a difference: Be a force for good with one dedicated day off for impactful volunteering, supporting causes close to your heart.Nurturing your career: Propel your career forward with abundant opportunities for on-site training, workshops, and personal development.Rewards that count: Reap the benefits of our comprehensive rewards package, including tuition reimbursement and a health spending account.Unleash your spirit: Join a thriving workplace culture filled with employee-led clubs, campaigns, sports teams, and exhilarating activities - fostering camaraderie and fun.Our ImpactBaylis Medical Technologies is a leader in the development and manufacturing of innovative medical devices in the fields of radiology and cardiovascular. Headquartered in Canada, the company also provides contract manufacturing services to some of the world's leading medical device companies.Baylis Medical Technologies is an equal opportunity employer and encourages applications from all qualified individuals.Please inform us if you require any accommodations during the recruitment process.Take the LeapWe are looking for talented individuals, like yourself, to join Baylis Medical Technologies and make a meaningful impact in the lives of patients. Be part of our mission to revolutionize patient care through cutting-edge technology and breakthrough solutions.Are you ready to join us? Apply today and let's shape the future of healthcare together!

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