Senior Project Engineer

Overview

The Senior Project Engineer is responsible for planning and executing various development activities for scPharmaceuticals’ drug-delivery device products, as well as establishing and maintaining Design History Files, working out of our Burlington facility.  The position is full-time, reporting to the Head of Product Development and Engineering.

Responsibilities

  • Create and maintain project plans pertaining to new product development and significant design changes
  • Create and maintain device design history files compliant with design control requirements
  • Create and maintain design specification traceability matrix
  • Create process document change orders
  • Create product requirements and criteria with measurable specifications
  • Develop and write engineering test plans, protocols, and reports
  • Conduct testing as needed
  • Manage activities with external vendors such as test laboratories
  • Provide input to the risk analysis process as it pertains to new product development and engineering change orders

Education and Experience Requirements

  • Bachelor’s degree in engineering or related area
  • Minimum of five years of medical device product development and manufacturing experience, preferably in drug delivery or related field

Knowledge, Skills and Ability Requirements:

  • Strong team player skilled at collaborating with internal and external key stakeholders in engineering, manufacturing, quality, and regulatory disciplines
  • Extensive knowledge of new product development and engineering change order processes and procedures
  • Strong background in new product development/product introduction including design controls per FDA regulations and guidance, engineering specifications, manufacturing and quality requirements
  • Demonstrated project management skills
  • Excellent communication and relationship building skills
  • Strong technical competency with a basic knowledge of medical device development, with drug delivery experience preferred
  • Exceptionally organized and detail-oriented with ability to effectively and efficiently execute plans
  • Proficient with MS Office suite
  • Solid decision-making skills

 

scPharmaceuticals is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

 

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