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Cytrellis Biosystems, Inc. · 4 months ago

Electro-Mechanical Manufacturing Engineer

Woburn,MA,US

Full-time

Onsite

Senior Level

5+ years exp

Cytrellis Biosystems, Inc. is seeking an Electro-Mechanical Manufacturing Engineer responsible for evaluating and refining manufacturing processes. The role involves collaborating with Contract Manufacturers, ensuring compliance with specifications and quality standards, and continuously improving manufacturing efficiencies.

BiotechnologyHealth CareMedical

Responsibilities

Develop and implement manufacturing processes to ensure products are manufactured to the required specifications and standards. This includes creating work instructions, assembly procedures, and fixturing for the manufacturing process

Work within the Engineering team to drive design for manufacturing and assembly early in the design process for new product development

Evaluate and troubleshoot electromechanical systems including boards, communications, mechanical, simple vacuum system and handpieces issues

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

Qualification

Manufacturing processes designLean ManufacturingSix-Sigma PrinciplesStatistical analysis softwareMetrology techniquesElectromechanical systems troubleshootingAnalytical skillsInterpersonal skillsPresentation skillsProblem-solving capabilities

Required

Bachelor's degree in Manufacturing Engineering, Mechanical or Electrical 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

Proven problem-solving capabilities and strong analytical skills

Preferred

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

Company

Cytrellis Biosystems, Inc.

Cytrellis is a medical technology company dedicated to the development and commercialization of first-in-class aesthetic devices which emphasize safety, efficacy, and improved quality of life for our patients.

Founded in 2012

Boston, Massachusetts, USA

51-200 employees