Responsibilities
Include but are not limited to the following:
• Define, create and communicate a commercialization path for new medical devices or pharmaceutical product solutions from concept creation through product development. • Create documentation to define system requirements and specifications, managing internal and external stakeholders, through development, validation, documentation and release of products. • Leads cross-functional project execution for platform technologies, ensuring compliance with ISO 9001 and ISO 13485 standards. • Act as a customer-facing representative for platform technologies, including participation in industry trade shows and technical discussions. • Collaborate with internal stakeholders including R&D, Regulatory, and site teams to ensure successful delivery of services related to pre-clinical to Phase II within oral solid dose drug development. • Assist in North America product sustainability as a technical lead, coordinating Operations, R&D, and Regulatory Teams for product recyclability initiatives to align with regulatory critical guidance. • Work with a multi-disciplinary product development team and cross business unit to develop, evaluate, document, and introduce new products. • Review all designs and validations to ensure all specifications are being met. • Conduct appropriate project risk assessments and define a mitigation plan. • Develop approaches to sustain and communicate success and progress across global stakeholders. • Support sales efforts in the bid process to gain repeat, and/or new, long-term business as needed. • Partners with Industrial Designers to incorporate sponsor user requirement specifications to create innovative solutions. • Work with intellectual property counsel to submit IP invention disclosure and ensure all data and drawings are provided for provisional applications. • Participate in monthly Project Phase Reviews and provide updates to assigned projects along with status update on current phase. • Runs concurrent projects effectively. • Other duties as assigned.
Qualifications/Education/Special Skills
Education • BS Degree in Engineering field (Chemical, Electrical, Mechanical, Biomedical, or related field) required. • PMP (Project Management Professional) certification strongly preferred.
Experience • 5-7 years of leading product development and project/program management experience within the Medical Device or Pharmaceutical industry. • Proven experience managing cross-functional teams and customer-facing projects. • Experience with IND, NDA, NDA 505(b)2, and ANDA drug development preferred. • Familiarity with ISO 9001 and ISO 13485 quality management systems and regulatory standards. • Experience with design verification, validation, and documentation processes. • Demonstrated success in mentoring and performance management of direct reports.
Technical Skills • Strong working knowledge of design controls and regulatory requirements (US, EU, Japan, China). • Proficiency in ICH-GCP/ISO 14155 and clinical research regulatory frameworks. • Skilled in documentation, testing, and design-control procedures. • Proficiency in statistical and analytical tools, including design of experiments (DOE). • Broad knowledge of polymeric materials and processing techniques (extrusion, injection molding, thermoforming) preferred. • Familiarity with sustainability and recyclability initiatives in product development.
Soft Skills & Tools • Excellent written and verbal communication skills; able to present to stakeholders at all levels. • Strong organizational and time management skills; capable of managing concurrent projects. • Ability to work independently and collaboratively in a virtual or cross-site environment. • Proficiency in Microsoft Office Suite (Project, Excel, Word, PowerPoint). • Ability to interface effectively with Sales, R&D, Regulatory, and Operations teams.