We Make Life More Rewarding and Dignified

Location: Libertyville
Department: Research & Development

SUMMARY:

The candidate will have product development and project management/leadership experience and will support the delivery of innovative new products as well as improving our existing product designs by successfully leading and/or participating in cross-functional Technology or New Product Development teams for global Ostomy care related projects.

The candidate will be responsible for developing and maintaining strong relationships with functional heads and senior leaders to gain the cross-functional support needed to drive commercialization of new products and/or significant updates to existing products which benefit our customers.

RESPONSIBILITIES:

Product Development

• Design and development of products, including high level design feasibility, prototype development, detailed design, test method development, design verification/validation, and product commercialization.
• Application of both new and existing technologies, materials and processes to deliver the optimum product design ensuring the establishment of excellent standards of performance.
• Liaise with clinicians and with customers to understand their needs and to therefore optimize product functionality and performance.
• Prepare technical documentation in accordance with regulatory and design control requirements.
• Develop a high level understanding of internal customer requirements.
• Conduct sophisticated analysis of data and develop detailed reports documenting results, conclusions and recommendations
  Project Leadership

• Plan, schedule, and control activities to fulfill objectives and satisfy project / product requirements. Ensure team deliverables are in compliance with the company’s product development and quality processes.
• Develop and maintain strong relationships with functional senior leaders to drive success.
• Lead the team in effective decision making and strategic analysis.

REQUIREMENTS:

• 5-8 years overall experience

• Bachelor’s Degree and minimum 5 years of relevant experience OR Master’s Degree (MS/MBA) and 3 years of relevant experience. Knowledge of a Regulatory environment, Medical Device environment preferred (Coursework/experience in 21 CFR, QSR 830, ISO 13485:2003, ISO 14971, Risk Management, etc.).
• Experience in medical device design principals, material selection, design concept validation and test method development

• Experience of working under medical device design controls, with proven knowledge of design verification, validation and design/process FMEAs
• Proven ability to manage and lead cross-functional teams to drive success of a project.
• Experience working in product development/commercialization preferred.
• Experience with project management tools and skills; with knowledge of process and project planning best practices.
• Proven ability to manage communication to keep key stakeholders appropriately engaged and informed to drive success of a project.
• Ability to balance planning and project focus with the need for flexibility to ensure successful execution.
• Excellent communication and interpersonal skills.
• Business acumen; ability to think from an overall “best for the business” perspective.
• Strong analytical, planning, organization and time management skills to effectively execute project plans and budgets.
• Ability to understand customer requirements and incorporate them into business decisions.
• Excellent presentation skills with the ability to communicate complex information to executive leaders.
• Experience of medical device regulations including GMP (Good Manufacturing Practices), QSR (Quality Systems Regulations) and ISO quality requirements
• Proficiency with MS Office suite
• Proficiency with CAD software (SolidWorks preferred)
  

Hollister Incorporated is an independent, employee-owned company that develops, manufactures, and markets products for ostomy care, continence care, and critical care and develops educational support for patients and healthcare professionals. We have been in business for more than 95 years. Our products are sold in more than 90 countries and we have manufacturing and distribution centers on three continents. At Hollister Incorporated, we are passionate about the work we do, and we are committed to making life more rewarding and dignified for our Associates and for the people who use our products and services. A career at Hollister Incorporated can take many paths, all of them leading to rewarding opportunities.

Job Req ID: 28720