Overview: The Manufacturing Engineer II role focuses on product ownership, regarding new product introduction (NPI) and sustaining activities. This role will be working cross-functionally to transfer new product lines, improve existing processes, and troubleshoot and mitigate failures across Sight Science's portfolio of market-leading ophthalmic technologies. Whether working on sustaining or NPI projects, this individual will be working with both internal teams and external partners to facilitate consistent, high-quality manufacturing while optimizing COGS. Additionally, this role will work closely with the R&D team, contributing to design transfer activities such as DFM, design verification, and process development.
The individual suited for this role should actively seek opportunities to contribute to projects, demonstrating initiative and a keen ability to drive team success through strong cross-functional collaboration. This person must be technically proficient, capable of rapidly learning and adapting, and excel in translating higher-level company or team objectives into actionable projects executed efficiently. They should embody flexibility, attention to detail, effective communication, and a commitment to both leadership and teamwork, ensuring that their contributions significantly advance the team's goals.
Responsibilities:
- Work with internal and external teams to identify and implement manufacturing improvements on existing product lines.
- Contribute to design transfer activities, working cross-functionally within the company as well as by coordinating transfer activities with external vendors, in order to build high-quality products in accordance with development and commercial goals
- Operate with moderate independence on manufacturing projects, driving them to a timely conclusion while meeting or exceeding all deliverables
- Define measurable requirements for contract manufacturers and external vendors
- Create robust and stable processes that ensure product quality and minimize COGS
- Support design development, including design verification and validation
- Generate internal and external facing documentation, including risk analyses, test protocols and reports, and transfer plans
- Develop and implement new manufacturing processes, equipment, and fixturing
- Analyze customer complaints, assess failure modes, and implement mitigations
- Ensure high-quality production at external manufacturing partners through process improvements, consistent monitoring of key metrics, a thorough review of process outputs, and maintaining validated lines
- Support overarching company goals, including but not limited to compliance with FDA regulations, ISO 13485, and any other applicable standards
- Actively foster a positive working environment through clear communication, a solutions-oriented mindset, and a pro-team mentality
Skills/Qualifications:
- Bachelor's or Master's degree in an applicable engineering field
- Minimum of three years of related medical device industry experience
- Experience with product development and post-commercial production of a medical device
- Familiarity with design verification and validation, risk management documentation, and process validation
- Proficiency with SolidWorks modeling, engineering drawings, tolerance analysis, and fixturing design
- Experience authoring controlled documentation, including formal protocols and reports, MPIs, LHRs, and BOMs
- History of effective collaboration with external partners, including CMs and vendors
- Strong communication skills, both with internal and external teams
- Ability to both work independently as well as part of a larger team
- Proficient in technical writing and utilization of MS Word and Excel
- Time management abilities and organization, especially when faced with projects across multiple product lines
- Actively foster a positive working environment through clear communication, a solutions-oriented mindset, and a pro-team mentality
- MS Project and statistical analysis software are desirable but not required
- Up to 20% travel time expected
- Willingness to travel to international vendors 2-5 times a year
- Sitting/standing: The role may require prolonged periods of sitting at a desk or standing during meetings, presentations, or customer interactions
- Computer use: Extensive use of computers and other electronic devices may be necessary for data entry, communication, and software navigation
- Phone calls: The job may involve frequent phone use for meetings and conference calls
- Multitasking: The ability to multitask and manage projects simultaneously may be required, which can be mentally demanding and occasionally stressful
For California, the base salary range for this position is $115,000-$155,600 (highly qualified) a year. The Company maintains highly competitive, performance-based compensation programs.
#LI-Hybrid