Sr. Product Development Engineer

Responsibilitiesarrow_right

* Lead and manage multiple cross-functional product development projects, ensuring on-time completion of deliverables while providing technical leadership throughout the product lifecycle.

* Prepare and lead design/development documentation, such as design input/output records, protocols, reports, and design history files in accordance with ISO, applicable regulatory and company standards.

* Translate customer requirements, user needs and/or other inputs into clear design requirements, specifications, and design input documentation (as applicable); participate in and lead risk management activities, design/project reviews, and verification testing to ensure product safety and efficacy; apply engineering analysis, design principles, and risk management tools to drive sound design decisions.

* Develop and evaluate prototypes, generate drawings/specifications, select appropriate materials, develop processes, and collaborate with suppliers to support device design, process development and manufacturing in compliance with regulatory and quality requirements.

* Lead process characterization and design verification activities, including test method development, fixture design, execution of testing, and documentation of results.

* Partner with customers/clinicians, marketing, regulatory, quality, NPI/manufacturing, and external experts to develop novel medical devices, assess new technologies/processes, and ensure clinical relevance and manufacturability of designs.

* Provide engineering support for design/process changes and product launches, resolving technical challenges and driving continuous improvement initiatives.

* Support audits and compliance activities as a subject matter expert.

* Participate in intellectual property activities by contributing to invention disclosures, patent strategy discussions, and design differentiation.

* May be asked to provide input to performance review

* Formally trains and mentors' junior staff, or acts as a resource for colleagues with less experience

* Support business development activities and opportunities.

* Strong interpersonal and communication skills dealing with internal and external customers.

Qualificationsarrow_right

* Bachelor's/University degree in Engineering (Mechanical, Biomedical, etc.), or related science/technical field.

* 8+ years' experience of engineering in medical device or related industry experience.

* Extensive knowledge and understanding medical device standards and regulations

* Extensive knowledge of GMP principles and their application in medical device manufacturing, including country
-specific regulatory requirements

* Knowledge of global regulatory requirements including risk management efforts and thorough risk assessments and mitigation strategies.

* Experience supporting customer/clinical studies, collecting data, and collaborating with customer/clinicians to ensure compliance with study protocols.

* Strong familiarity with rapid prototyping techniques.

* Experience with 3D solid modeling and technical drawings of medical devices desirable.

* Execution of Design for Manufacturability (DFM) principles and process characterization activities to design and develop products that are manufacturable and cost effective.

* Strong experience with Project Management (including organizing and facilitating meetings, project planning, balancing multiple projects, and budgeting) and Project management tools (e.g. MS Project).

* Knowledge of biocompatibility requirements and expertise in selecting appropriate materials for medical device applications and incorporating human factors engineering principles to optimize medical device usability and user experience.

* Knowledge of IP laws and practices, including patent applications and protection of proprietary technologies.

* Proven ability to lead cross-functional teams to achieve project objectives.

* Leadership skills in establishing and managing comprehensive design control processes, ensuring adherence throughout the product lifecycle.

* Ability to work independently and also lead small teams in a fast-paced, results-oriented environment.

* Ability to generate complex prototypes using various materials and techniques to test and validate product designs.

* Ability to effectively communicate complex technical issues and solutions to non-technical internal and/or external customers in both oral and written methods.

* Ability to create and maintain technical documentation, such as design specifications and test reports.