R&D Professional
We are seeking an accomplished R&D professional to lead our product development activities. As the successful candidate, you will be responsible for coordinating and directing all aspects of product development, including integration of regulatory affairs, quality assurance, operations, clinical, marketing, sales, and packaging engineering.
Your key responsibilities will include:
* Coordinating and/or directing all aspects of product development activity related to a product line;
* Working with operations and supply chain to deliver a new product to market in line with division and operational goals;
* Creating and tracking project schedules, plans, and budgets for the development of a new product (or line extension) and assessing department priorities;
* Making assignments to direct reports to ensure projects and company priorities are met;
* Coordinating with cross-functional peer and team members, internal and external suppliers, and outside professionals to ensure department projects are developed to plan;
* Proposing and facilitating the selection of a new product's manufacturing location;
* Overseeing the transfer of new products to manufacturing locations;
* Designing and developing innovative medical devices through project planning, prototype development, testing, characterization, analysis, and reporting;
* Managing assigned department personnel;
* Developing and implementing new processes and procedures;
* Reviewing and approving verification and validation protocols and reports;
* Training NPD teams, R&D technicians, and engineers on new design and process development procedures as well as division procedures and policies;
* Supervising and mentoring R&D teams through New Product Development activities;
* Creating, controlling, and managing a department budget (expense and capital expenditure);
* Critiquing engineering cost analysis;
* Supporting manufacturing, quality, regulatory, and R&D to ensure systems are compliant with all internal and external guidelines;
* Supporting design and process root-cause analysis and supporting non-conforming product and complaint investigations.
To be successful in this role, you will need:
* A bachelor's degree in mechanical engineering, biomedical engineering, chemical engineering, or other related engineering discipline with a biomedical engineering or bioengineering degree preferred;
* 8+ years of industrial experience in R&D or process development, preferably in a medical device or other regulated FDA/QSR and ISO environment;
* Demonstrated knowledge of development, manufacturing, and quality system requirements for medical devices or comparably regulated environments;
* Experience in process validation (IQ, OQ, and PQ), writing protocols, and reports to support verification and validation activities for product commercialization and executing validation;
* Ability to create and deliver project plans and lead multifunctional teams;
* Excellent oral and written communication skills, with strong demonstrated skills in communicating with all levels of technical and operating management;
* Strong ability to analyze and use technical data and resources;
* Proficiency in statistical software;
* Training in Six Sigma or Design for Six Sigma.
At our organization, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations while also recognizing the importance of flexibility and work-life balance. We are committed to fostering an inclusive, growth-centered, and rewarding culture where you can learn, grow, and thrive.