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Lead Manufacturing Engineer
2 months ago
Position Overview:
The Manufacturing Engineer plays a crucial role in enhancing production efficiency and facilitating the introduction of new products. This includes the design and validation of new product SKUs, as well as the development of continuous improvement strategies for assembly processes to align with corporate objectives for commercial success and operational excellence.
Key Responsibilities:
- Implement design and process enhancements, providing innovative solutions for product improvements, cost efficiency, and production scalability.
- Develop and document test methodologies and protocols, conduct validation activities, and prepare comprehensive technical reports.
- Establish processing capabilities and author processing instructions aimed at minimizing risks and optimizing production performance.
- Utilize 3-D printing and other tools to prototype fixtures and manage vendor relationships for controlled components.
Collaboration and Compliance:
- Represent the Manufacturing team in cross-functional collaborations, ensuring adherence to Design for Manufacturing (DFM) principles.
- Generate detailed component and assembly drawings related to existing components and fixture modifications.
- Design, document, troubleshoot, and implement new or upgraded production equipment and fixtures.
- Participate in supplier selection and qualification processes, as well as Non-Conformance Report (NCR) and Corrective and Preventive Action (CAPA) initiatives.
Quality Assurance:
- Prioritize quality by employing a risk-based approach to ensure compliance with risk management policies and Good Manufacturing Practices (GMP).
- Contribute to the company's intellectual property strategy and support adherence to FDA Quality System Regulations (QSR), ISO 13485, and other relevant regulations.
Team Dynamics:
- Foster a positive team environment and promote morale within the department.
Qualifications:
- A minimum of 5-7 years of relevant experience in the medical device sector, specifically in manufacturing or operations.
- A degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or a related field.
- Proven experience in generating and managing manufacturing documentation for commercial medical devices, including Manufacturing Process Instructions (MPIs), Lot History Records (LHRs), Bill of Materials (BOM), and flowcharts.
- Proficiency in Onshape or SolidWorks for modeling, engineering drawing generation, DFM, tolerance analysis, and tooling design.
Preferred Skills:
- Familiarity with process validation, GMP, and advanced manufacturing techniques.
- Demonstrated ability to utilize various design tools and prototyping methods to develop and validate new concepts.
- Strong coaching and training capabilities for production staff.
- Excellent decision-making skills and sound judgment appropriate for a senior-level role.
- Proficiency in Microsoft Office Suite; experience with statistical analysis software is advantageous.
Work Environment:
This position operates in a professional office setting, with many responsibilities potentially performed remotely. Standard office equipment such as computers, phones, and photocopiers will be utilized. Personal Protective Equipment may be necessary for specific tasks, and the role may involve lifting moderately heavy items.
Physical Requirements:
Regular mobility is required, with periods of prolonged sitting or standing at a computer.
Compensation:
The starting base salary for this position ranges from $139,000 to $170,000 annually, depending on experience and qualifications. Additional benefits include stock options, a 401(k) plan with matching contributions, fully covered medical/dental/vision insurance for employees, generous PTO, and daily company-paid lunches.
Equal Opportunity Employment:
Neptune Medical is committed to providing equal employment opportunities to all applicants and prohibits discrimination and harassment of any kind.
