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Defibtech is seeking a Manufacturing Engineer responsible for supporting Defibtechs product manufacturing from early prototype through end-of-life phases, as well as the production process and equipment used to build and test our product. The Manufacturing Engineer also provides technical guidance and insight into the manufacturing process and serves as a key role that facilitates project transfers, while expanding the organizations broader understanding of the manufacturing process. This position is based onsite at our manufacturing facility in Branford, CT.

Core Responsibilities:

• Interfaces closely with engineering, quality, and regulatory functions to resolve issues on the production floor, process deviations, CAR/SCAR reports, and vendor RMAs.
• Writes station specifications, test protocols, and work instructions as needed.
• Participates in activities related to Material Review Board (MRB) and root cause investigations.
• Reviews vendor changes; leads and/or partners with sustaining team on obsolescence issues.
• Assists with the day-to-day maintenance of the production test stations, both in-house and remotely with contract manufacturers.
• Quickly addresses and resolves technical manufacturing issues to minimize downtime.
• Opens investigations, determines root causes, and provides solutions.
• Performs trend analysis on production and field data to identify and track potential issues.
• Identifies cost savings opportunities and partners with contract manufacturers to identify and realize regular efficiency improvements and cost reductions.
• Monitors and gathers feedback from contract manufacturers, recognizes opportunities and provides input for technical innovation and process improvement.
• Assists in transferring new products or redesigns from RandD to production.
• Creates and reviews engineering configuration Bill of Materials (BOM) for pilot and production lifecycle product, including zero quantity items like RoHS requirements and build documentation.
• Coordinates project related tasks within manufacturing, external suppliers, and contract manufacturers.
• Acts as a Manufacturing core-team project member on cross-functional project initiatives.
• Responsible for managing documentation flow within our existing change control process and facilitating appropriate reviews, release, and distribution to required parties.
• Reviews drawings for complete manufacturing and inspection criteria, fixturing considerations and overall manufacturability.
• Provides critical link in the transition of technical documentation release between engineering and manufacturing departments and our contract manufacturers.
• Demonstrates Defibtechs values on the job. Promotes and participates in continuous improvement.
• Actively supports compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including but not limited to FDA, Quality Systems Regulations, safety regulations and applicable statutes).

Qualifications / Requirements:

Bachelors degree in a relevant field (technical, engineering or manufacturing) and at least 1 year of related manufacturing experience in a regulated environment OR the equivalent combination of education, training, and/or experience.

Preferred candidates will possess a bachelors degree and 3 or more years of related manufacturing experience.

An understanding of electronics, components, schematics, PC board manufacture and electro-mechanical assembly are strongly preferred for this role.

Experience within the medical device industry and Lean and/or Continuous Improvement (Six Sigma) training and experience is highly desirable.

Ability to coordinate and lead investigations, identify root cause, and implement corrective actions.

Ability to operate independently, drive project initiatives related to manufacturing, influence decisions, and ou comes, and drive tasks to successful completion.

Strong written and oral communication skills to accurately convey issues and information.

Ability to multi-task and work in a fast paced, high-volume environment.

Strong documentation skills including generating requirements, specifications, test protocols, work instructions, workflow diagrams, etc. Previous experience with document/enterprise management systems and applications is desirable.

Must be an initiative-taker and self-motivated contributor; a collaborator that can work well with others across an organization.