Job SummaryThe position will guide the development of medical devices, dietary supplements, cosmetics, and/or OTC/ANDA/NDA drugs. Manage and oversee all aspects of product development projects. This position will be responsible for leading collaborative, multifunctional teams consisting of R&D personnel, quality, regulatory, manufacturing, and product divisions.
Job DescriptionResponsibilities:
- Manage corporate priorities, and ensure team alignment across functional areas to ensure that project deadlines and goals are met.
- Manage the product development process utilizing an iterative agile project management framework.
- Independently oversee a portfolio of projects and ensure that project and divisional goals are aligned.
- Develop, communicate, and track project plans, objectives, budgets, scope, timelines, and projected end dates.
- Translate project goals into project tasks.
- Conduct risk assessments to identify issues that may cause project delays or cost overruns and develop contingency plans to mitigate the impact.
- Compile risk profiles associated with scope creep and changing project requirements.
- Maintain team morale and engagement by ensuring constant and transparent communication.
- Compile technical justifications and data summaries in support of product claims. Lead process improvement initiatives.
- Represent Medline on various ASTM/AAM/ISO technical committees and contribute to the development of new test standards.
Qualifications;
- Bachelor's degree in Engineering or Science related field.
- At least 2 years of experience in a medical device or pharmaceutical related field.
- Project management
- Microsoft Project.
- Knowledge of medical device requirements (Class I-II), design controls, risk assessments, and the 510k process.
- Position may require travel up to 10% of the time for business purposes (domestic and international).
Preferred Qualifications:
- PMP Certification.
- Experience in the development and launch of new medical/pharma products.
Benefits - Medline is committed to offering competitive benefits and a variety of choices to best meet the needs of you and your family. For employees scheduled to work at least 30 hours per week, this includes health and well-being, financial fitness, career development, paid time off and more. Employees scheduled to work less than 30 hours per week can participate in the 401(k) plan, access the Employee Assistance Program (EAP), Employee Resource Groups (ERG) and Medline Service Corps. For a more comprehensive list of our benefits, please click here.Every day, we're focused on building a more diverse and inclusive company, one that recognizes, values and respects the differences we all bring to the workplace. From doing what's right to delivering business results, together, we're better. Explore our Diversity, Equity and Inclusion page here.Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.