Associate Director, Medical Devices and Combination Products Human Factors & Design Controls

Job content

Job Description

HOME BASED - The Associate Director of Medical Device and Combination Products (MDCP) is a key technical leader within our Global Phamaceuticals operations technology team. Under general scientific and administrative direction, you’ll leverage your experience gained on scientific/technical/business issues to support project teams and other technical staff. Ideally you’ll demonstrate advanced skill and knowledge of Human Factors Engineering, Design Controls and Risk Management to create and optimise business, technical, and compliance processes. You’ll participate in high impact, complex, cross-functional and cross-divisional teams and initiatives and provide significant leadership to achieve project goals. Effective collaboration with teams is essential to meet Organon’s goals/objectives.

You will also support the development and maintenance of medical devices and combination products for contraceptive, fertility and inhalation products.

Consequently, having a first-class knowledge of human factors engineering, design controls, medical device risk management, material science, pharmaceutical packaging/labeling and related scientific/technical concepts and techniques are essential for this position. The ability to execute in a fast-paced operating environment to resolve issues and meet customer needs in a compliant manner are at the core of this position. You will routinely face competing priorities, and must manage time effectively, while keeping stakeholders and team members informed with effective communication.

This includes leading, enabling or consulting in the development and execution of related strategic plans for problem-solving and continuous improvement by working with internal and external partners. Key interfaces include sites, External Manufacturing, R&D, Quality Ops, Product Development groups, Regulatory Affairs, Procurement and suppliers.

Responsibilities

• Lead human factor engineering (HFE) activities across Organon including the development and implementation of the company’s Quality Management System requirements for HFE.
• Provide cross functional teams the voice of the intended user when developing and validating the product’s packaging and label/labelling.
• Develop, execute and report HFE Formative and Summative studies for Organon’s medical devices and combination products.
• Develop and approve the company’s records for all HFE and associated use-related risk management activities.
• Collaborate with other development teams to ensure HFE requirements are captured in the product’s Design Controls.
• Develop HFE capabilities within MDCP-Technical Operations and, where appropriate, by utilising external HFE vendors/SMEs.
• Lead the development of responses to Competent Authority questions concerning the use of Organon’s medical devices and combination products.
• Provides candid, timely and tactful communication and feedback to team and collaborators
  
  

Behaviours

• Understands the criticality of securing early sponsorship and stakeholder alignment for projects and initiatives.
• Operates effectively as a leader in assigned roles on projects, or as MDCP technical operations representative on multiple 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.
• 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.
• Ensures expectations are met on a consistent basis and works with a long-term perspective to address customer needs.
• 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 organisation and builds high performance teams.
• Speaks/presents effectively to both internal and external audiences to influence change and build consensus.
  
  

Required Education, Experience And Skills

• Likely to be degree educated or equivalent experience.
• Subject matter expert in Human Factors Engineering, design controls, and risk management.
• Significant understanding and demonstrable application of medical device or pharmaceutical regulations from major markets, e.g. USFDA cGMPs, EMA.
• Significant experience with medical device or combination product commercialisation, operations support, and materials/components.
• Experience medical device, pharmaceutical or in biotech organisations either in product development and/or Operations.
• Knowledge of sterile and non-sterile medical devices and combination products.
• Development and commercialisation of medical devices and combination products.
• Proficiency in project management, from conception and initiation, through close-out.
• Experience leading and enabling diverse teams.
• Effective communicator who routinely provides feedback and coaching to team members and collaborators
• Excellent oral and written communication skill
  
  

Preferred Experience And Skills

• Experience in the development/operations of medical devices or combination products, such as inhalers, implants or injectable drug delivery systems,
• Experience in plastics injection molding, and polymer processing is highly desired.
• CAD/2D drawing creation experience; test method development and validation; tolerance stack analysis.
• Lean Six Sigma Green Belt or higher certification.
• Development of intellectual property and technical analysis of published intellectual property.
  
  

Search Firm Representatives Please Read Carefully
Organon & Co., Inc., Jersey City, NJ. USA , also known as Organon & Co., Inc., Jersey City, NJ. USA , does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status

Regular

Relocation:
No relocation

VISA Sponsorship

Travel Requirements:

Shift

Flexible Work Arrangements:

Valid Driving License

Yes

Number Of Openings

Hazardous Material(s):

1

Requisition ID:R501053