Job Category: EngineeringJob Description:CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values - dedicated, innovative, friendly, partners, and do the right thing - our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women's and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more atResponsibilities:
Manage cost/quality improvement and vertical integration projects to ensure the projects are completed on-time, within budget, and meeting all functional and business system requirements.
Manage the production support services. Namely, identifying and resolving repetitive and major production issues that are affecting department performance, especially when resolutions of such issues require technical solutions.
Manage component substitutions, BOM changes, validations, implementations and cutover management when required.
Manage the engineering services employees specific to Costa Rica. Namely Manufacturing Engineers and all site Technicians.
Manage the validation efforts within the Costa Rica factory to ensure equipment, personnel, processes and materials can produce products meeting specifications.
Ensure that all areas of responsibility operate within the business system requirements and the regulations.
Set, motivate and develop team to ensure flawless project execution and continuous improvement mindset.
Develop annual goals/objectives and communicate to the Management Team to achieve consensus, support and buy-in for technical programs.
Keep relevant stakeholders informed of Costa Rica projects and ensure frequent and timely follow-up on deliveries from stakeholders outside CR engineering team, such as technical operations, regulatory affairs and product management.
Perform other duties as directed by management.
Qualifications:Knowledge, Skills and Abilities:
Strong knowledge and understanding of manufacturing medical devices / life science regulations including FDA/GMP, ISO-13485, EU MDR, among others.
Excellent analytical and problem-solving skills, with the ability to analyze complex data sets and identify improvement opportunities.
Process development and New Product Introduction experience from beginning through end.
Strong project management and change management skills required.
Creative individual who is able to communicate and coordinate good ideas through implementation. Ability to communicate well, both orally and written.
Thorough understanding of medical device manufacturing, especially as it relates to FDA (GMP) manufacturing requirements
Strong interpersonal skills, team player.
Proficiency in English (B+).
Work Environment:
Ability to work in dynamic environments.
Get into productions rooms.
Experience:
A minimum of 8 years' experience in manufacturing environment that is both labor and machine intensive.
At least 5 years of relevant managerial experience on the field.
Education:
University Degree in Mechanical, Chemistry, Biomedical Engineering, Microbiology or related field.
