Job description
- The Sr. Product Quality Engineer will serve as a technical representative providing design quality expertise to a product development team.
- Responsible for maintaining a strong collaborative partnership with cross-functional team members to achieve patient/user safety, customer satisfaction, and organizational success.
- This individual will be leading and managing a risk management team but could also work on other items.
- Looking for someone well rounded from a development quality perspective.
- Lead and/or support on-time completion of Design Control deliverables.
- Support the establishment of objective, measurable, and verifiable product requirements.
- Support Design Verification and Validation planning & execution, including any cross-functional investigation & resolution activities.
- Lead Risk Management activities from product concept through commercialization.
- Support test method development and lead test method validation activities.
- Support manufacturing process development & qualification for new product and design changes.
- Support the establishment of component specification definitions, supplied component sampling plan development, and vendor qualifications Support biocompatibility and sterilization qualifications.
- Support audits and quality system improvement activities.
- Support Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements.
- Comply with Client, U.S. FDA, EUMDR and other requirements, as applicable.
- Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and suppliers.
- Bachelor's degree in engineering or Technical Field.
- Minimum of 5 years of experience in R&D, Process/Manufacturing Engineering, and/or Quality with at least 2 years supporting product development.
- Experience in medical devices and associated regulations/standards.
- Experience in test method development and validation.
- Experience in preparing risk assessments, FMEA and other risk documents.
- Advanced Degree in Engineering/Technical Field.
- Experience in active implantable medical devices.
- Knowledge of requirements management tools (e.g., DOORS) and use of problem reporting systems (e.g., JIRA).
- Working knowledge of statistics and its application to verification and validation ".
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Frequently asked questions
Q: What skills or qualities help someone succeed as a Senior Product Engineer?
A: To succeed as a Senior Product Engineer, key technical skills include expertise in software development methodologies (e.g., Agile, DevOps), proficiency in programming languages (e.g., Java, Python), and knowledge of cloud computing platforms (e.g., AWS, Azure). Additionally, strong soft skills such as effective communication, leadership, and problem-solving abilities are crucial for collaborating with cross-functional teams, prioritizing tasks, and driving product development. These technical and soft skills enable Senior Product Engineers to drive innovation, improve product quality, and lead high-performing teams, ultimately supporting their career growth and effectiveness in the role.
Q: What is the career path for a Senior Product Engineer?
A: A Senior Product Engineer's typical career progression involves starting as a Product Engineer or Software Engineer, progressing to a Lead or Technical Lead role, and eventually becoming a Senior Product Engineer or Engineering Manager. Key opportunities for skill development and growth include mastering product development methodologies, learning to manage cross-functional teams, and developing expertise in areas such as product design, user experience, and technical leadership. Long-term career prospects for Senior Product Engineers may include transitioning into executive roles like VP of Engineering, Chief Technology Officer, or even starting their own product development companies.
