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Senior Manufacturing Engineer
2 months ago
Position Summary: The Senior Manufacturing Engineer role is centered around product stewardship, particularly in the realms of new product launch (NPL) and ongoing support initiatives. This position entails collaborating across various departments to facilitate the transition of new product lines, enhance current manufacturing processes, and address and resolve issues within Sight Sciences Inc.'s renowned ophthalmic technology offerings. Whether engaged in ongoing support or new product launch projects, this individual will liaise with both internal teams and external collaborators to ensure consistent, high-quality production while optimizing cost of goods sold (COGS). Furthermore, this role will closely partner with the Research and Development team, contributing to activities such as Design for Manufacturability (DFM), design validation, and process innovation.
Key Responsibilities:
- Collaborate with internal and external stakeholders to identify and execute enhancements in manufacturing for existing product lines.
- Participate in design transfer initiatives, working cross-departmentally within the organization and coordinating with external suppliers to produce high-quality products that align with development and market objectives.
- Independently manage manufacturing projects, ensuring timely completion while meeting or surpassing all established deliverables.
- Establish measurable criteria for contract manufacturers and external partners.
- Develop and implement robust processes that guarantee product quality and minimize COGS.
- Support design development efforts, including design verification and validation processes.
- Create comprehensive documentation for both internal and external stakeholders, including risk assessments, testing protocols, and transfer plans.
- Innovate and implement new manufacturing processes, tools, and fixtures.
- Analyze customer feedback, evaluate failure modes, and execute corrective actions.
- Ensure high-quality output from external manufacturing partners through process enhancements, regular monitoring of key performance indicators, thorough review of process results, and maintenance of validated production lines.
- Support overarching organizational objectives, including compliance with regulatory standards such as FDA regulations and ISO 13485.
- Promote a positive workplace culture through effective communication, a solutions-oriented approach, and a collaborative mindset.
Qualifications:
- Bachelor's or Master's degree in a relevant engineering discipline.
- A minimum of three years of experience in the medical device sector.
- Experience in product development and post-launch production of medical devices.
- Familiarity with design verification, validation processes, risk management documentation, and process validation.
- Proficient in SolidWorks for modeling, engineering drawings, tolerance analysis, and fixture design.
- Experience in creating controlled documentation, including formal protocols and reports.
- Demonstrated history of effective collaboration with external partners, including contract manufacturers and suppliers.
- Strong communication skills for interaction with both internal and external teams.
- Ability to work autonomously as well as part of a larger team.
- Proficient in technical writing and skilled in using MS Word and Excel.
- Excellent time management and organizational skills, particularly when managing multiple projects across various product lines.
- Willingness to travel internationally for vendor visits as required.
Work Environment: The role may require extended periods of sitting or standing during meetings and presentations. Frequent use of computers and electronic devices will be necessary for data entry and communication.
