Product Development Engineer
il y a 5 jours
Science is a clinical stage, vertically integrated technology company focused on solving some of neuroscience's hardest questions and most serious unmet medical needs. We work to restore quality of life to those with debilitating conditions for which there are no treatment options, creating devices aimed at restoring vision, cognition, and mobility to patients who have lost it. To support progress across our industry, we provide state-of-the-art components and vertically integrated infrastructure for others to build on via Science Foundry.
**Role responsibilities**:
- Define and maintain product requirements, ensuring proper flowdown to system components and maintaining traceability.
- Lead technical reviews by sharing key product specifications, gathering feedback, and assessing impacts with component owners and stakeholders.
- Develop and implement risk management strategies by formalizing mitigation methods and integrating them into the overall requirements list.
- Prepare verification strategies aligned with internal procedures, industry standards, and FDA guidance.
- Manage supplier selection processes and oversee execution of outsourced studies.
- Document verification and validation protocols and reports, including ex-vivo and in-vivo preclinical studies as needed.
- Provide product-based responses to regulatory and quality checklists.
- Drive continuous product improvements by incorporating clinical feedback, market data, and test results into proposed product evolutions.
- Ensure all activities comply with the Quality Management System and applicable regulations.
**Key qualifications**:
- Bachelor's or Master's degree in Engineering or a related field
- Minimum 3 years of experience in system design within a highly regulated industry
- Solid knowledge of systems development methodologies, risk analysis, and regulatory compliance.
- Exceptional communication skills (both written and verbal) in English
- Proven track record of delivering results in complex, cross-functional environments.
- Highly organized, detail-oriented, and capable of synthesizing information for diverse stakeholders.
- A collaborative team player with the ability to facilitate technical discussions effectively.
- Motivated to go above and beyond for product success and customer satisfaction.
**Preferred qualifications**:
- Experience with Visual Restoration Systems or similar technologies.
- Familiarity with FDA regulations and global medical device standards.
- Proficiency in documentation tools and traceability software.
- Proficiency in an additional European language.
- Hands-on experience with preclinical testing (ext-vivo/in-vivo studies).
- Strong analytical and problem-solving skills.
**Salary/Pay Range**:
Science is required under California law to include a reasonable estimate of the compensation range for this role. We determine your level based on your interview performance and make an offer based on the indicated salary band. If located in California, the base salary range for this full-time position is $120,000 - $ 150,000 annually + equity + benefits. Within the range, individual pay is determined by several factors, including job-related skills, experience, and relevant education or training. Please keep in mind that the equity portion of the offer is not included in these numbers.
Science Corporation is an equal opportunity employer. We strive to create a supportive and inclusive workplace where contributions are valued and celebrated, and our employees thrive by being themselves and are inspired to do their best work.
We seek applicants of all backgrounds and identities, across race, color, ethnicity, national origin or ancestry, citizenship, religion, sex, sexual orientation, gender identity or expression, veteran status, marital status, pregnancy or parental status, or disability. Applicants will not be discriminated against based on these or other protected categories or social identities. Science will also consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state and local law.
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