Senior Manager, Combination Product Development

About the role

This is an Individual Contributor position, reporting to the Director of Device Development and Technology. This individual is knowledgeable in the field of combination products & drug delivery devices. Primary expertise should be demonstrated in engineering, device quality systems (CFR 820, ISO 13485), human factors engineering principals, risk management for medical devices (ISO 14971), etc. The successful candidate should demonstrate strong technical writing and presentation skills and be able to translate technical information to non-technical audiences.

Responsibilities

• Support the vision for the Device Development function
• Work with members of Device Development and Technology, and other functions including Packaging, Supply Chain, Clinical Supplies Operations, Quality Control, Regulatory and Quality Management to support strategies for product and process improvements
• Develop and support the strategic activities of the department
• Evaluate new and innovative delivery device technologies to support new and life-cycle management projects
• Create, maintain, and update device related documents required for regulatory filings and compliance
• Facilitate studies as required
• Write protocols, reports, specifications, procedures, change control requests, technical assessments, etc.
• Program management of Device projects
• Develop project plans and corresponding project management tools to support the execution of all projects
• Manage cross functional teams (including 3rd party resources)
• Execute Human Factors Engineering & Usability activities

Qualifications/ Required Knowledge/ Experience and Skills

• 5-8 years’ experience in Pharmaceuticals, Medical Devices, Biotechnology, or other related industries
• In-depth understanding of device verification including functional testing, process validation/verification, quality assurance, and regulatory requirements as they pertain to and devices
• Ability to work strategically and independently with internal and external groups
• Demonstrated leadership skills especially the management of high-visibility project teams
• Demonstrated knowledge of parenteral delivery devices (syringes, self/ or auto-injectors), etc.
• Self-Starter: ability to solicit & obtain time-sensitive information from various internal & external project stakeholders
• Able to deliver high level to detailed level status reports on programs, projects and portfolio information
• Utilizes experience, presentation and influencing skills to facilitate successful team discussions and outcomes
• Competency in use of business and project management computer software (such as MSProject and MSOffice)
• Experienced with usability testing / user studies / human factors
• Able to operate effectively in a fast-moving dynamic environment

Qualifications/ Required Knowledge/ Experience and Skills (continued)

• Bachelor’s degree in a related Engineering discipline (Mechanical, Electrical, Biomedical, etc.)
• Masters or advanced degree preferred

Pay

$150,034.00 - $224,250.00, plus incentive opportunity

Schedule

Frequent domestic and international travel up to 15-20% or as required by the project

Benefits

Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.