Senior NPI Engineer - HYBRID

As a Senior NPI Engineer at RefleXion, you will be responsible for leading the engineering efforts in the development and commercialization of complex electromechanical devices designed for cancer treatment. Your core responsibilities will include establishing production processes, collaborating with design engineers to ensure safety and performance standards are met, and documenting manufacturing assembly processes. Additionally, you’ll be troubleshooting machine failures and conducting rigorous quality assessments through pFMEA risk assessments.

To excel as a Senior NPI Engineer at RefleXion, candidates should hold a Bachelor’s degree in mechanical, electrical, biomedical engineering, or a related field, along with a minimum of six years of relevant experience in environments related to Manufacturing or R&D in medical devices. Experience in integrating and troubleshooting complex robotic electromechanical systems, along with a solid understanding of medical device regulations, is also essential.

RefleXion offers a hybrid work model for the Senior NPI Engineer position, allowing you to work from home while being based in the greater San Francisco Bay Area. Depending on your role’s needs, you can expect to commute to the Hayward office 1-4 days a week, balancing remote work with crucial in-person collaboration.

At RefleXion, Senior NPI Engineers have numerous opportunities for career development. You will engage in leadership initiatives, mentor junior engineers, and take part in dynamic projects that evolve with technological advancements in cancer treatment. The company encourages professional growth through workshops, lunch ‘n learns, and other educational events to expand your skill sets.

In the role of Senior NPI Engineer at RefleXion, you will lead various projects focused on the development and refinement of electromechanical systems used in cancer therapy. You will manage projects from initiation to production launch, engage in the design transfer process, and drive feature upgrades, ensuring that the devices meet the highest safety and performance standards.

Sure! When answering this question, focus on specific projects where you successfully integrated robotic systems. Highlight your role in the process, the challenges you faced, and how you overcame them. Mention any relevant tools and methodologies, like DFM or FMEA, that you utilized to ensure successful integration.

In your response, outline the types of validations you've handled, such as IQ, OQ, PQ, and any relevant metrics used to assess processes. Discuss the significance of each validation in the context of medical device development to exhibit your understanding of stringent quality controls.

Explain your systematic approach to troubleshooting by possibly using examples. You might cover how you identify root causes, gather data, and implement corrective actions to avoid repeat issues. Additionally, mentioning any tools that facilitate this process would be beneficial.

Be specific about the types of documentation you’ve created, such as schematics, MPIs, BOMs, and other manufacturing support documents. Share how this documentation has contributed to product quality, easiness of assembly, or compliance with regulations.

Discuss your experience with risk assessments such as pFMEA and how you apply process controls. Describe your commitment to quality assurance and any methodologies employed to ensure products meet safety and efficacy requirements.

Share a specific project highlighting your leadership roles and the steps taken throughout the project lifecycle. Cover project objectives, team collaboration, challenges faced, and successful outcomes to demonstrate your project management skills.

Prepare to discuss any specific instances of navigating FDA regulations. Share what challenges arose and how you resolved them, emphasizing adherence to quality standards while maintaining productivity.

Illustrate your communication strategies and collaborative efforts, discussing how you address any conflicts or misalignments between departments. Highlight role-playing, meetings, and cross-functional teams you’ve forged collaborative environments with.

Be ready to explain how you’ve successfully navigated these regulatory standards in past roles. Share how you implemented specific processes and overcame challenges to align product development with regulatory expectations.

Discuss your methods for staying informed, such as attending industry conferences, participating in professional organizations, engaging with training opportunities, or following relevant publications. This showcases your commitment to continuous learning.