[Immediate Start] Lead Product Engineer

1 day ago

Cork, Ireland Morgan McKinley Full time

Lead Product Engineer

Our client, a leading global healthcare company specializing in pharmaceutical distribution, medical supplies, and healthcare information technology is hiring a Lead Product Engineer. This position plays a crucial role in setting strategies and ideating the right private label products for customers and patients. This newly-created role involves working throughout the entire product life cycle, from conception to end-of-life, including voice of the customer (VOC) analysis, designing, testing, competitive benchmarking, developing product requirements and specifications, enhancing existing product functionality, and understanding FDA regulations and quality system requirements for own-branded medical products.

This is a Senior-level Individual Contributor role (SME) and requires close collaboration with cross-functional leaders and teams, including marketing, sourcing, product management, category management, sales, business insights, and quality assurance, to ensure products meet customer needs, are cost-effective, and comply with FDA and other regulatory standards. Candidates must be able to work onsite for meetings and collaboration as needed in the Richmond, VA Medical-Surgical business unit hub.

Responsibilities:

Product Ideation

- Develop and implement new product strategies.
- Lead technology development and work with external vendors to evaluate new concepts and conduct product research and testing.
- Perform thorough user needs analysis to develop product requirements and specifications.
- Lead the requirement definitions, research, metrics analysis, technical specifications, development, testing, KPIs, and other launch efforts.
- Conduct industry and competitive analysis to identify new opportunities in the medical device and healthcare industry.
- Continuously monitor industry trends within product development engineering and develop strategies to stay ahead of the competition.
- Analyze current trends and provide market insights to drive new product development.

New Product Development

- Guide a team of product development managers in developing innovative medical device products.
- Prioritize the right product features and benefits for new product development with suppliers and contract manufacturers.
- Conduct customer research to define segments and identify needs to inform the product roadmap.
- Work with Product Development Managers to manage product roadmaps, align business and technical needs, analyze data, turn customer insights into actionable initiatives, determine rollout strategy, and manage risks.
- Define vision and strategies using best practices, identifying market opportunities, and building product business cases.
- Create and manage budgets to ensure cost-effectiveness of research and development activities.

Product Testing & Benchmarking

- Develop a comprehensive product testing and benchmarking program for various product categories.
- Assist in building in-house knowledge and skills for experimental work, clinical research, and new product development projects.
- Conduct research to evaluate new technologies and test product design concepts.
- Ensure compliance with all applicable medical device regulations and standards (ISO13485, FDA 21 CFR 820, ISO 14971, etc.).
- Develop and implement policies and procedures to ensure product quality and safety.
- Maintain laboratory space and equipment as needed.
- Outline work proposals and coordinate with vendors.
- Documentation, Data Analysis & Quality Systems
- Follow best practices during new product development, ideation, and implementation of research procedures, SOPs, and test methods.
- Gather input, design experiments, work with labs to perform test method validations, summarize and interpret data. Complete data reduction and analysis using statistical/engineering tools.
- Play an active role in the design history process with specific responsibilities for documenting requirements, product specifications, verification, and validation activities.
- Knowledge of FDA/ISO risk management techniques and their application. - Prepare technical reports and documentation to communicate key information, competitive benchmarking data, and facilitate product launch decision-making.
- Teamwork, Communication & Collaboration
- Build collaborative relationships with key stakeholders by aligning product development business goals, communicating testing results, new product ideas, and product roadmaps, and gaining executive leadership buy-in.
- Provide overall direction by analyzing business objectives and customer needs.
- Establish and manage relationships with key stakeholders, partners, and vendors.
- Develop and maintain a culture of innovation and collaboration.

Minimum Requirements:

- Degree or equivalent and typically requires 10+ years of relevant experience. Less years required if candidate has relevant Master's or Doctorate qualifications.
- S. in Engineering, Sciences, or a related field.
- At least 10 years of experience in product engineering, product development, or product management.
- Strong problem-solving and analytical skills with high attention to detail.
- Effective communication and presentation skills at all levels of the organization.
- Ability to work in a team environment both locally and globally.
- Excellent prioritization and organizational skills with project management experience.
- Demonstrated experience in taking design requirements from concept through final design.
- Experienced in design for six sigma or similar engineering practices. Ability to apply engineering analysis techniques and tools (SolidWorks, Matlab, Minitab, Excel, etc.).
- Proven ability to work independently to research and solve technical issues.
- Hands-on experience in conducting product research in a lab/engineering setting.
- Ability to travel up to 20%

Our Ideal Candidate:

Track record of success in research and development.

Experience applying VOC tools to select new products.

Strong knowledge of engineering test methods to assess various product functions.

Experience in the medical device industry is preferred but not required.

Good understanding and application of technical principles, device functionality, theories, and concepts in IV therapy, needles and syringes for injection and infusion, wound care, surgical devices, and kits.

Knowledge of FDA regulations and 510k pathways.

Experience in product management, preferably with a deep understanding of the medical device and healthcare market. - Proven record of successfully leading product engineering teams in developing innovative products, preferably within the healthcare industry. - Strong problem-solving skills and a passion for innovation and collaboration.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

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