What are the responsibilities and job description for the Principal Manufacturing Engineer position at BioTalent?
Job Title : Principal Manufacturing Engineer
Job Summary :
The Principal Manufacturing Engineer plays a critical role in driving continuous improvement within our high-volume medical device manufacturing environment. This highly impactful position will lead and execute complex projects, develop and implement innovative manufacturing processes, and mentor junior engineers.
Key Responsibilities :
- Process Development & Optimization : Lead the development and optimization of manufacturing processes for new and existing medical devices, ensuring robust, efficient, and cost-effective production.
- Utilize Lean Manufacturing principles (e.g., Six Sigma, Kaizen, 5S) to identify and eliminate waste in the manufacturing process.
- Conduct process capability studies, analyze data, and implement corrective actions to improve yield and reduce defects.
- Develop and validate new manufacturing equipment and tooling.
- Project Management : Lead and manage cross-functional projects related to process improvement, equipment upgrades, and new product introductions.
- Develop project plans, timelines, and budgets, ensuring projects are delivered on time and within scope.
- Effectively communicate project progress, challenges, and solutions to stakeholders.
- Technical Expertise : Deep understanding of manufacturing processes relevant to medical devices (e.g., injection molding, assembly, packaging, sterilization).
- Proficient in statistical analysis tools and software (e.g., Minitab, JMP).
- Strong knowledge of quality systems and regulatory requirements (e.g., ISO 13485, FDA regulations).
- Team Leadership & Mentorship : Mentor and guide junior manufacturing engineers in their professional development.
- Foster a collaborative and high-performing team environment.
- Provide technical expertise and guidance to production personnel.
- Continuous Improvement : Continuously seek and implement innovative solutions to improve manufacturing efficiency, quality, and cost-effectiveness.
- Stay abreast of the latest industry trends and technologies in manufacturing.
Qualifications :