The candidate will work at the interface between product development and assembly process development.

The candidate will provide technical direction and leadership in exploration, evaluation and development of (critical) process parameters from early stage product development to commercial launch of combination products.

The candidate will also serve as a single point of contact to coordinate the combination product control strategy of multiple products with ability to work across multiple Drug Products and Manufacturing Sites. The candidate will also support the strategic direction of developing the assembly strategy, including technology transfer and Critical Process Parameter alignment across multiple assembly equipment and manufacturing sites.

Specific responsibilities of the Principal Engineer of R&D includes but not limited to:

• Guide project team activities to meet project and business with specific focus on assembly process development and development of the control strategy

• Drive team accountability for process improvement and implementation, helping to communicate the importance of process development throughout the organization.

• Demonstrate business acumen, project management, communication, process management and team performance management; ask the right questions to understand business impact and risks

• Make the complex simple and represent a true enterprise view when communicating opportunities and plans to the team and organization

• Lead team through options analysis and drive multi-functional recommendations

• Evaluate different assembly technologies with a multitude of device and primary container platforms.

• Use scientific and engineering judgement, generate data where needed. Coordinate the assembly process development within the framework set by the Quality Management System and the Regulations and align dates and expectations with key stakeholders.

• Understand technological advancements, environmental changes, key competitor’s offerings; and provide analysis on technological feasibility, I/P landscape, risk assessment, and sales and market considerations

• Strong knowledge of FDA Design Controls/ISO13485 and medical device product development experience required. Strong knowledge and demonstrated successes in the development of drug-device assembly processes.

Facilitation & Risk Management

• Excel at enterprise leadership and facilitation, collaboration, attention to detail Identify and recommend the best enterprise business proposition

• Engage teams in healthy debate, and deliver solutions

• Scope definitions and control: stakeholder alignment, project planning, resource and risk management, project leadership, team development and communication

• Lead teams in use of ongoing risk management & communication tools

• Proactively identify and call out risks and issues to relevant stakeholders; lead development and delivery of tactical and achievable mitigation and contingency planning

Project Execution

• Develop a project plan, and then deliver the project plan to achieve business results

• Provide demonstrated proficiency in MS Project.

• Deliver transparent, timely and effective verbal and written communication to teams, stakeholders and appropriate levels of the organization

• Lead "lessons learned" exercises, share lessons among project leaders and other teams, integrate lessons into existing processes, tools and templates.

Qualifications:

A minimum of a BS degree Mechanical or Biomedical or related engineering field and twelve (12) or more years of related engineering experience; or an MS degree in Electro- Mechanical, Mechanical, Electrical or Biomedical engineering and ten (10) or more years of related engineering experience is required. Experience in medical device industry with developing Class II and/or Class III medical devices is required. Experience in process development is required. An in-depth understanding of current medical device regulatory requirements, including Quality System Regulation and Device Design Control is essential in this role. A strong working knowledge of device design, development, and verification and validation and design transfer requirements is required. Experience in applying general engineering principles, materials, design for manufacturability, and reliability to achieve product design requirements is required. Must be able to apply risk management methodologies and experience with Failure Mode Effects Analysis (FMEA) is required.

Must be self-motivated to handle challenging and difficult engineering problems while maintaining project timelines. Thorough working knowledge of device manufacturing and validation requirements is an asset for this position. Demonstrated strong communication skills on both technical and business issues with all levels of management, internal customers, and external vendors are necessary. Demonstrated problem-solving, analytical and project management skills are required. Ability to identify, select and manage outside vendors in conducting all aspects of device assembly work is essential for this position. Ability to work both independently as well as lead teams and projects is required. There may be up to 20% travel in this position, both domestic and international.

• Excellent oral, written, and presentation communication skills are required

• Experience in General Management thinking & approach; working through end-to-end business challenges and solutions is required

• A proven record of Project management, leading multifunctional teams and cross-functional team management experience is required; multi-discipline experience preferred

• Demonstrated ability to work through influence, negotiation and partnering is required

• Prior experience working on Growth and/or execution Growth projects is preferred

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