Executive Job Description | Our client is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics.
In the role of Sr. Research Engineer, he/she would perform as a discipline expert, driving functional performance by designing and developing new and improved products that contribute to significant financial success to the division. He/she would serve as an independent reviewer to subordinates, peers, and senior management.
Key Duties, Activities and Responsibilities:
- Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
- Sets discipline strategy in alignment with functional goals and key engineering objectives.
- Achieves functional goals.
- Develops key engineering objectives.
- Collaborates with experts within function to integrate engineering objectives into activities associated with development of new/improved products or technology.
- Advances engineering expertise across functions.
- Proactively advises and shares opinions with subordinates, peers, and senior management.
- Mentors and trains functional leaders.
- Develops network valued by functional leaders. Actively supports open exchange of expert discipline knowledge.
- Deepens insight to current and emerging business challenges enabling functional goal achievement.
- Ensures quality and effectiveness of key results of major project plans within function through sound design, early risk assessments, and implementation of fallback strategies.
- Anticipates challenges.
- Creatively applies knowledge of concepts, principles, and theories.
- Develops and continually advances engineering direction.
- Sources and identifies emerging trends from multiple internal and external sources.
- Assesses relevance.
- Determines use of innovation.
- Integrates trends into functional short-term objectives.
- Advances cross-discipline technology and direction.
- Applies imagination.
- Generates institutional knowledge.
- Creates, invents, and implements new or better approaches, alternatives, and breakthrough ideas that are valued by customers within the function.
- Develops and advances existing and breakthrough technology.
- Presents engineering concepts and results for function engineering and non-engineering leaders as well as potential and existing partners.
- Maximizes impact and value of expertise.
Additional Responsibilities May Include:
- Organizes internal engineering seminars
- Maintains external reputation as discipline expert.
- Influences industry with presentations, serving on panel discussions at industry meetings, attending industry meetings, or authoring articles for peer-reviewed publications.
- Provides advice and counsel with respect to regulatory strategy. Collaborates with internal regulatory experts to ensure compliance with schedules for NDAs/INDs/sNDAs/INDA/CE/IDE and 510 k submissions
- Selects, builds and maintains the most appropriate vendor partnerships.
- Evaluates vendor reliability and performance ensuring adherence to plans, policies, and procedures to provide required products or services.
- Establishes collaborative relationships.
- Manages conflicts.
- Achieves compromise.
- Ensures the multiple discipline, functional team is making good decisions regarding design, materials, manufacturing, quality, costs, regulatory compliance, intellectual property, and strategic fit within the product portfolio.
- Merges many ideas into a cohesive plan to ensure that functional goals and respective project plans maintain momentum and meets timelines.
- Solicits feedbacks to better understand unmet market needs.
- Integrates inputs into discipline strategy to successfully achieve functional goals.
- In negotiations, gathers and understands the relevant facts supporting optimal decisions where value or resources are not left on the table, risks can be pro-actively managed, and desired ongoing partnerships and longstanding relationships are the result.
- Ensures work is performed only on strategically valued, practical, and revenue generating products.
- Develops strong awareness of other disciplines/subsystems dependencies and challenges to appropriately modify own strategy and performance goals to avoid performance tradeoffs.
- Provides top line and/or secondary review of design results.
Work Experience, Skills and Education Required:
- Proven ability to innovate with a history of successful new or improved product releases.
- Ability to advise the various functions within the division on how they can manage their particular risks.
- Interacts well with diverse groups within R&D and maintains strong working relationships with internal and external collaborators.
- Listens and understands others points of view and articulates tactfully and respectfully ones own perspective orally, in writing and in presentations.
- Works well with other engineers in a collaborative, fast paced goal-driven environment.
- Interpersonal skills to negotiate & reconcile interdisciplinary differences optimizing overall organizational goals.
- Technical background in healthcare, nutritional products, laboratory diagnostics, medical devices, or pharmaceutical companies.
- Experience with Drug/Device combination product development required.
- Mechanical Engineering degree with experience in drug/device combination product development from design concept through commercial manufacture.
- Working knowledge of Medical Directive and FDA Device and combination Product requirements including Human Factors testing.
- Demonstrated skills as a Team leader, project manager and experience working with third party developers and manufacturers.
Preferred Qualifications:
- Demonstrated experience with sterile dose forms and delivery.
Education:
PhD in Engineering or related field with 1-5 years of significant product life cycle experience; or MS in Engineering or related field 1-5, years of significant product life cycle experience; or BS in Engineering or related field with 1-5 years of significant product life cycle experience.
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