The Advanced Manufacturing Engineer is responsible for developing and implementing manufacturing processes and selecting appropriate manufacturing partners to help bring our next generation technology to market. The Advanced Manufacturing Engineer will be involved early in the design process to establish a pathway to production and to ensure that products can be manufactured to specifications. The position may be required to perform all, or a combination of the following essential responsibilities as determined by necessity. This role is located at the Company’s Woburn, MA office.
Essential Duties and Responsibilities:
Education and/or Experience:
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Essential Duties and Responsibilities:
- Develop and implement manufacturing processes to ensure products are manufactured to the required specifications and standards. This includes creating work instructions and assembly procedures for the manufacturing process.
- Evaluate and select third-party manufacturers capable of producing products to the required standards and timelines. This includes reviewing the manufacturers' capabilities, capacity, and quality systems.
- Manage the manufacturing process to ensure that the products are manufactured to the required specifications and timelines. This includes monitoring the manufacturing process, identifying and resolving issues, and ensuring that the products meet the required quality standards.
- Ensure that the manufacturing process and products comply with all relevant regulations, standards, and guidelines. This includes working with regulatory agencies to obtain necessary approvals and certifications.
- Collaborate with cross-functional teams, including product development, quality assurance, supply chain, and logistics, to ensure the successful manufacturing and delivery of products.
- Continuously improve manufacturing processes to optimize efficiency, reduce costs, and improve quality. This includes identifying opportunities for improvement and implementing process changes.
- Conduct supplier audits to ensure that the third-party manufacturers are complying with the required standards and regulations. This includes conducting on-site visits and assessments of the manufacturers' quality systems and processes.
- Manage relationships with third-party manufacturers to ensure that they are meeting the required performance standards. This includes communicating performance expectations, addressing performance issues, and negotiating contracts and pricing
- Contribute to FMEAs and risk documentation as technical subject matter expert.
Education and/or Experience:
- Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, or Industrial Engineering or equivalent job experience.
- 5+ years of related engineering experience, preferably in new product development environment. Medical device experience desired.
- Proficiency designing and developing manufacturing processes, work instructions, and test fixtures.
- Familiarity with Lean Manufacturing and/or Six-Sigma Principles.
- Familiarity with SPC and Statistical Sampling techniques.
- Excellent interpersonal and presentation skills, with the ability to clearly present recommendations and ideas and to summarize complex issues.
- Ability to work well under pressure in a fast-paced, time-sensitive environment with shifting priorities, and multiple deadlines.
- Experience using statistical analysis software is a plus.
- Experience in metrology techniques is a plus.
- Experience working with a variety of manufacturing and prototyping methods.
- Proven problem-solving capabilities and strong analytical skills.
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