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Senior Process Engineer

Company: SurModics
Location: Eden Prairie
Posted on: June 6, 2021

Job Description:

Ready to make a difference by utilizing your talents? Join a team driven by a mission to help patients, and a culture focused on developing medical device and diagnostic solutions.

Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company's expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease.

A Senior Process Engineer in our Engineering Department would be expected to:

Responsibilities

Leads engineering process development (50%)

  • Leads the development and characterization of pilot-scale manufacturing processes
  • Prepares detailed experimental plans and coordinates execution with technical team members
  • Reviews experimental data and provides statistical and other technical analysis
  • Considers experimental outcomes, project and manufacturing objectives, and recommends next steps
  • Supports vendor and other external process qualification
  • Assures readiness for pilot-scale manufacturing and clinical builds
  • Supports the transfer and validation of manufacturing processes

Communicates throughout organization (30%)

  • Communicates experimental plans, outcomes, and recommendations to project team and R&D leadership
  • Prepares clear, concise, and accurate technical reports and laboratory notebook records
  • Assists with patent and regulatory filings
  • Prepares pilot-scale manufacturing documentation

Maintains an organized and effective manufacturing environment (20%)

  • Plans and recommends equipment and facility needs to support R&D projects
  • Leads the design, build, and qualification of manufacturing equipment, tools, or facility space
  • Leads efforts to improve laboratory or manufacturing procedures or methods

Quality Assurance and Safety Responsibilities

  • Performs responsibilities in compliance with the quality systems as described in SurModics' Quality Manual.
  • Adheres to all company safety, health and hygiene policies, procedures, and directives, including neatness of lab bench and general use areas.

Skills and Experience

  • BS or advanced degree in engineering or related discipline
  • 5+ years overall process development experience
  • Medical device or pharmaceutical process development experience preferred
  • Demonstrated ability in process characterization and experimental design
  • Strong engineering and problem solving skills
  • Ability to verbally communicate technical plans and outcomes
  • Strong skills in the preparation of written technical reports

Surmodics offers a competitive compensation and benefits package, including a bonus program, 401(k) with employer match, employee stock purchase plan and stock options.

Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Keywords: SurModics, Eden Prairie , Senior Process Engineer, Other , Eden Prairie, Minnesota

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