Engineering Manager (Product Development Engineering)

Posting Date 4 weeks ago(5/2/2022 9:57 AM)
Requisition ID
2022-10562
Job Location(s)
West Lafayette IN United States
Travel
Less than 10%
Position Type
Full Time
Company
Cook Biotech Inc.
Category
Engineering

Overview

The person in this position assumes responsibility for leading an engineering area with the objective of developing first-generation products from new or existing technology platforms, products and processes. This position may also provide direction and insights to improve upon current product designs and support next-generation and line-extension development of current products.  This person provides both technical review and management oversight for areas of design control and risk management.  Additionally, this person provides guidance, leadership, and mentorship to engineers and project team participants at Cook Biotech Inc.

Responsibilities

Product Development Activities

  • Develops and fosters new ideas for product applications from technology platforms and first-generation products within the local team.
  • Leads the execution of the feasibility process to assess viability of projects through organizing, collecting and assessing in vivo and in vitro
  • Collect and review information to generate Service Agreements to external partners. Provide oversight and stewardship for execution of Service Agreements with the engineering team.

Design Control and Risk Management Processes

  • Provides technical oversight and review for Design Control and Risk Management, including design plan deliverables, user needs and design input requirements, V&V testing, and risk analysis.
  • Engage internal functions, business partners, and healthcare professionals to gather user requirements, design requirements, and to coordinate development activities.
  • Remain current and apply the understanding of FDA, ISO 13485/14971, and Quality System Requirements.
  • Conduct and coordinate design control and risk management activities, including reviewing the overall design risk profile and ensuring risks are appropriately controlled and mitigated.
  • Conduct and coordinate engineering activities to develop products according to project timelines.
  • Foster effective internal and external communication in the transfer of products to Manufacturing.

Personnel Development

  • Conducts employee performance evaluations and wage reviews. Ensures employee training is current and adequate for the job duties assigned. 
  • Mentors Engineers and other functional area project members
  • Conduct other corporate duties when required

Project Management

  • Provide leadership to the engineering team to ensure project timelines are achieved.
  • Provide project management education, resources and tools to ensure engineering teams achieve goals per customer request.
  • Communicate resource needs, tasks and changing priorities to other areas of the company.
  • Communicate project status to partner representatives and other Cook Biotech functional areas.
  • Works to resolve project obstacles and challenges
  • Ensures accuracy in effort-tracking and accounting for Service Agreement projects.

Innovation and Continuous Improvement

  • Submits invention disclosures to further the Cook Biotech innovation pipeline. Contributes to building the Cook Biotech Intellectual Property portfolio.  Fosters discovery and invention within local teams.
  • Fosters continuous improvement and leads initiatives to improve functional efficiency of CBI processes.
  • Encourages innovation in device design and usability.
  • Routinely interacts with healthcare professionals and partners to expand knowledge of end-user requirements.
  • Ensures design control procedures and risk management procedures are efficient and effective; updates systems accordingly for new compliance requirements.

Qualifications

  • Master’s degree in engineering with emphasis in biomedical or chemical engineering preferred. Other relevant engineering disciplines may be considered with commensurate experience.
  • Five to ten years of industry experience in medical device development preferred; or directly relevant educational/academic experience may be accepted.
  • Minimum of 2 years personnel development/supervisory and management experience directly with engineers.
  • Sufficient background to generally understand medical and biotechnology terminology.
  • Excellent written and verbal communication skills.
  • Proven ability to lead and manage projects.
  • Proven ability to communicate and work constructively with colleagues to establish and achieve mutual goals.
  • Proven ability to manage multiple projects.

Physical Requirements/Work Environment

  • Limited exposure to hazardous chemicals used in the manufacture of the product.
  • Physical demands are typical of an office and classroom environment.
  • Willing to work with material derived from animal tissues.

Employee Requirements

  • Sign non-competition and confidentiality agreements. Compliance with all policies of the company including without limitation the COOK Employee Manual, COOK Code of Conduct, COOK Electronic Information Policy, HIPAA regulations, and COOK Policy & Guidance on Interaction with Healthcare Professionals.

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