Device Process Engineer/Manager

Location:

RTP North Carolina

Overview:

Satsuma Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic for the acute treatment of migraine.  Our lead drug candidate, STS101, is a drug-device combination of a proprietary dry-powder formulation of dihydroergotamine mesylate, or DHE, capable of being quickly and easily self-administered by a proprietary pre-filled, single-use, nasal delivery device.  STS101 is currently being evaluated in a Phase 3 clinical trial.

Purpose:

This newly developed Device Process Engineer/Manager role will report to the Head of Manufacturing and oversee all aspects of the work of the external device suppliers to ensure a robust supply chain.  This includes development of injection molding/blow molding processes at suppliers to meet the product requirements in preparation for commercialization.  The role will also require some device design and engineering.

Duties and Responsibilities:

  • Responsible for the development of the device manufacturing strategy to ensure a secure supply chain for development and commercial products.
  • Develop and implement risk mitigation strategy and plan for device supply chain for a drug-device combination product.
  • Work to reduce cost of goods of device components.
  • Working closely with our Quality Director, establish quality agreements for device supply.  Responsible for technical aspects of these agreements.
  • Working closely with our Supply Chain Manager, establish supply agreements. Responsible for technical aspects of these agreements.
  • Responsible for device design and engineering tasks and/or outsourcing of them, with oversight of any outsourced work.
  • Responsible for STS101 design control.

Minimum Requirements Education/Experience:

  • Bachelor of Science in Mechanical Engineering, Process Engineering, Material Science or a closely related field.
  • Minimum of 5 years’ experience in controlling injection and blow molding process for medical devices in drug-device combination products.
  • Minimum of 5 years’ experience in the development of medical devices under Design Control (21 CFR 820) and ISO 13485; 2D/3D CAD expertise.
  • Minimum of 5 years’ experience on risk management per ISO 14971 and ICH Q9.
  • Minimum of 3 years’ experience in managing suppliers.
  • Have a proven track record of delivering projects on time within budget.

Behaviors/Skills:

  • Excellent communication skills with an ability to work in cross-functional teams, including across multiple sites.
  • Takes accountability for actions, drives results, learns from mistakes; is direct and truthful and therefore widely trusted –delivers on promises, goals and expectations.
  • Executes combination product development projects on time, in scope, and within budget.  Assume project leadership role with responsibility for technical product engineering, design transfer, and secondary packaging.
  • Works closely with the cross-functional team to assure project success.
  • Performs engineering analyses to ensure that products being developed (both internally and externally) are technically robust with reliable and sufficient performance.
  • Identifies areas of project risk, escalates issues and risks in an expedient manner, and actively proposes solutions.
  • Assures work activities are conducted in a manner compliant with all applicable regulations and industry standards.
  • Maintains a culture of continuous improvement that strives to ensure product safety and efficacy while accelerating delivery of commitments.
  • Makes quality decisions with limited supervision.

For additional information:

Please send your resume or CV to us at careers@satsumarx.com