Device Design Control Engineer

Position Summary:

The Device Design Control Engineer works within Product Development team and is responsible for drug/device combination product design and development through direction of contract development and manufacturing partners. The position reports to the Senior Director, Product Development & Engineering.

 

Responsibilities:

  • Manages drug/device combination product design controls of current and developing products
  • Provides project management oversight, establishes relationships and coordinates with CMOs for design control activities
  • Oversees implementation of design changes and ensures engineering verification activities are completed
  • Reviews and provides feedback to contract organizations on methods, techniques and evaluation criteria for obtaining results; interprets data to provide technical guidance
  • Arranges outsourced testing and documentation for design and development of combination products
  • Authors documentation of design and development, design changes, process changes, and risk analyses
  • Coordinates efforts with Quality Manager/Regulatory Affairs personnel
  • Supports cost modeling efforts
  • Assists in supplier audits
  • Supports technology assessments for future potential business opportunities supporting company business development initiatives

 

Experience and Qualifications:

  • Bachelor’s degree in mechanical, biomedical, industrial engineering (or similar) discipline required
  • Minimum five years drug delivery device design control experience required
  • Experience outlining plans and leading others through execution of projects

 

Skills and Abilities:

  • Strong technical writing skills
  • Project management skills
  • Ability to interface effectively with all levels of the organization and external partners
  • Strong facilitation, leadership and interpersonal skills
  • Ability to travel domestically and internationally 10-20 percent per month

 

Values:

  • Accountability: You… See it. Own it. Solve it. Do it. You possess a high degree of personal responsibility with a similar expectation of your team and colleagues.
  • Commitment to Patients and Health Care Providers: You have a passion for creating strategic, innovative, valuable, and high-quality solutions and products with a hands-on approach.
  • Teamwork: You confer with others to reach resolutions that are acceptable by all parties involved. You can multi-task and productively manage complex situations involving cross functional teams.
  • Integrity: You possess and demonstrate a high level of emotional intelligence and professionalism in your decision making. You unfailingly act with integrity and respect for colleagues, business partners and customers in all business dealings.
  • Value Driven: You produce consistent, high quality and quantity of outputs and meaningful results that contribute to strategic goals.
  • Empowered Communications: You possess and demonstrate strong communication and interpersonal skills.

EEO Statement

scPharmaceuticals is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

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