Manufacturing Engineer (Electrical Engineering) - ONSITE

The Manufacturing Engineer at RefleXion holds crucial responsibilities including ensuring compliance with safety and quality regulations, generating manufacturing documentation, conducting training for technicians, and leading cross-functional improvement initiatives. You will utilize your engineering expertise to enhance assembly processes, resolve nonconformance, and contribute to the overall operational excellence crucial for our groundbreaking SCINTIX® therapy.

To qualify for the Manufacturing Engineer role at RefleXion, candidates need a Bachelor’s of Science degree in Electrical Engineering and a minimum of 2 years of experience in manufacturing, NPI, or R&D engineering, particularly involving electrical sensor systems. Additionally, knowledge of FDA QSR's, ISO 13485, and lean manufacturing principles is highly beneficial.

The Manufacturing Engineer contributes to RefleXion's goals by streamlining manufacturing processes for our innovative SCINTIX® radiotherapy device. By supporting assembly, ensuring quality compliance, and facilitating continuous improvement initiatives, you play a vital role in enhancing productivity while upholding the highest standards of quality and efficiency in our operations.

The uniqueness of the Manufacturing Engineer role at RefleXion lies in its position within a pre-IPO, innovative healthcare start-up environment. In addition to the technical challenges, engineers have the opportunity to be involved in groundbreaking projects that directly contribute to advancements in cancer treatment, allowing for personal and professional growth along with a chance to make a significant impact in the healthcare sector.

Success as a Manufacturing Engineer at RefleXion hinges on a blend of technical and interpersonal skills. A deep understanding of electrical engineering principles, experience with test software, and familiarity with lean manufacturing practices are critical. Coupled with strong communication, teamwork abilities, and a keen attention to detail, these skills create an environment for innovation and excellence.

The work environment for a Manufacturing Engineer at RefleXion is dynamic and collaborative, set in a vibrant startup atmosphere that encourages innovation. With a strong emphasis on teamwork, you will engage with diverse departments and be part of a mission-driven culture focused on overcoming cancer challenges through cutting-edge technology.

RefleXion offers a competitive benefits package for its Manufacturing Engineers, which includes salary ranging from $70,000 to $110,000, stock options, medical and dental coverage, flexible spending accounts, paid time off, and numerous employee wellness programs. There are also opportunities for professional development, catering to a fulfilling work-life balance.

When answering this question, highlight specific projects or roles where you managed manufacturing processes. Discuss your understanding of high-power equipment, as well as any direct experiences with sensor systems. Mention how you ensured compliance with safety standards and quality regulations in those contexts.

Explain your structured approach to problem-solving, perhaps using the PDCA (Plan-Do-Check-Act) methodology or root cause analysis. Provide an example illustrating how you resolved a manufacturing challenge, emphasizing your analytical skills and ability to work collaboratively with teams.

Highlight your familiarity with process validation methodologies, including IQ, OQ, PQ, and TMV. Share specific instances where you executed process validations and how those contributions enhanced product quality and accessibility in manufacturing.

To answer this question, identify a specific process improvement project you spearheaded. Discuss the initial challenge, the steps you took to implement changes, the outcome, and how it benefited the overall manufacturing process, focusing on quality, efficiency, or cost reduction.

Talk about your familiarity with creating and maintaining manufacturing documentation like BOMs, travelers, and change orders. Mention any processes you followed to enhance documentation standards and ensure compliance with industry regulations.

Mention specific tools you have utilized, such as LabView, C, C++, or Python. Discuss the context in which you used these tools, the types of tests conducted, and how they contributed to the overall quality of manufacturing processes.

Discuss your thorough understanding of FDA QSR and ISO 13485. Provide examples of how you've ensured compliance in past roles, such as conducting audits, training staff, or implementing corrective actions.

Explain your methods for task prioritization, such as using project management tools or a priority matrix. Offer specific examples where this approach has helped you successfully manage competing deadlines in a manufacturing environment.

Describe the importance of teamwork in manufacturing engineering, highlighting how collaboration with cross-functional teams can lead to innovative solutions and improved outcomes. Share any experiences where teamwork was critical for project success.

When asked this question, express your enthusiasm for contributing to RefleXion’s mission in advancing cancer treatment through innovation. Discuss how the company's recent breakthroughs and focus on quality align with your professional values and aspirations in the field of medical engineering.