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Associate Director, Medical Device and Combination Products Cramlington United Kingdom,  

MSD (company)


Posted on : 16 April 2017

Project Description


Description
  • Our company  is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. 
  • Today, we are building a new kind of healthcare company  one that is ready to help create a healthier future for all of us.
  • Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.
  • To this end, we strive to create an environment of mutual respect, encouragement and teamwork. 
  • As part of our global team, you ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.




Responsibilities:
  •  Understands the criticality of securing early sponsorship and stakeholder alignment for projects and initiatives.
  •  Understands the big picture, and how activities link to company strategy and business goals.
  •  Operates effectively as a leader in assigned roles on projects, or as PTO representative on multiple small teams.
  •  Displays ownership and makes informed cost/ benefit decisions based on analysis of inputs, outcomes, risks and likely return.
  •  Demonstrates the necessary Inclusion skills to integrate inputs and perspectives from various sources, and communicates the decision and its Risk/Benefit implications to key stakeholders and sponsors.
  •  Continuously undertakes professional development activities to improve skills
  •  Utilizes engineering expertise to develop value-add solutions to customer needs.
  •  Solicits feedback to ensure that customer/stakeholder needs are the cornerstone of his/her decisions, expectations are met on a consistent basis, and works with a long-term perspective in addressing customer problems.
  •  This engineer demonstrates the appropriate Culture in interactions with others
  •  Actively supports and applies the various initiatives and goals of MMD and the company.
  •  Ensures expectations are met on a consistent basis, and works with a long-term perspective to address customer needs.
  •  Utilizes design control expertise to develop value-add solutions to customer needs in medical devices and combination products
  • Acts as a catalyst for change
  •  Facilitates the re-allocation of roles and responsibilities across team members to facilitate goal achievement and personal development.
  •  Contributes to developing technical skills in organization and builds high performance teams.
  •  Speaks/presents effectively to both internal and external audiences to influence change and build consensus.
  •  Continually improves communication systems and practices within and across teams/units/functions.
  •  Proactively reviews own performance and progress, and seek feedback from manager/peers/stakeholder to close gaps.
  •  Provides candid, timely and tactful communication and feedback to team and collaborators.
  •  Utilizes engineering expertise to develop value-add solutions to customer needs in medical devices and packaging


Qualifications
Education:


 Required:
Technical BS degree or higher (MS or PhD)  

Preferred:
BS in Mechanical Engineering, chemical engineering, biomedical engineering, materials engineering, pharmaceutical Sciences or similar.     


Required:
  •  A minimum of 8 years of experience in medical device, pharmaceutical or in biotech organizations.
  •  Significant experience in the regulations of major markets in the Pharmaceutical industry, e.g. USFDA cGMPs, EMA.
  •  Significant experience with medical device or combination product commercialization, operations support, and materials/components.
  •  Experience using quantitative decision tools for Risk Management and options analysis.
  •  Subject matter expert in design controls, deviation management, change control, and the fundamentals of documentation structure/ systems.
  •  Proficiency in project management, from conception and initiation, through close-out.
  •  Demonstrates company Leadership Behaviors.
  •  Experience leading and enabling diverse teams.
  •  Takes an end-to-end view of the supply chain to understand upstream/ downstream impact of actions taken at any node.
  • The engineer applies the following competencies in a manner that challenges and enhances overall operational effectiveness and routinely provides feedback and coaching to team members and collaborators on these skills
  •  Completing all activities with the highest regard for all company divisional and local site procedures for safety, quality, and regulatory compliance.
  •  Provide technical leadership to medical device and combination product manufacturing sites and functional areas, including the preparation of official documents
  •   Excellent oral and written communication skills


Preferred:
  •  Experience in design control, risk analysis and change control management for medical device or combination products
  •  Knowledge of sterile and non-sterile combination products.
  •  Experience with Drug Delivery Systems is highly desirable.
  •  Lean Six Sigma Green Belt or higher certification
  •  Experience in plastics injection molding, and polymer processing is highly desirable.


Offer:
  • Our employees are the key to our company s success. 
  •  We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.  
  • Our Company s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.

 
    Job Segment:  Medical, Manager, Biotech, Engineer, Law, Healthcare, Management, Science, Engineering, Legal                       

Locations

Cramlington GB

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