Manager, R&D

Job Description

About CooperSurgical:

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. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.

CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians. More information can be found at www.coopersurgical.com.

Job Summary:

This is a high visibility and high impact leadership position responsible for CooperSurgical’s In vitro fertilization (IVF) Media product line ― specialized solutions used to support the growth and development of embryos outside the human body during the IVF process.

As the R&D Manager you will be responsible for all aspects of Media product portfolio support including methods development, line extension, product improvements, business continuity as well as technical support for new markets registrations. This is the technical leadership position that is expected to have strong communication skills in order to drive an effective cross-functional collaboration with Manufacturing, Regulatory, Quality, Medical Affairs and Commercial functions.

This position reports to the Senior Manager R&D Product Engineering and can be based in Costa Rica, Houston, TX or Livingston, NJ.

Responsibilities

Essential Functions & Responsibilities:

• Manage a team of Product Engineers, full ownership of functional excellence by driving technical rigor, process discipline and timely execution in compliance with all applicable policies and best practice guidelines.
• Responsible for people development and performance management of a small to mid size team.
• Responsible for product evaluations, test methods development and product validation activities associated with IVF Media product development, improvements and changes.
• Provide biological assessments and risk mitigation support to manufacturing plant(s) in support of process development, maintenance and improvements.
• Program, project and/or task management of R&D workstreams associated with IVF Media related initiatives.
• Providing adequate documentation and technical inputs in support to regulatory and commercial business continuity and growth opportunities.
• Aid and drive an effective cross-functional collaboration ensuring timely and efficient delivery of target business outcomes.
• Drive and/or oversee definition of design inputs (i.e., product requirements) and technical strategies for an adequate verification and validation approach associated with IVF Media products.
• Present to the senior and executive leadership.
• Manage and influence internal stakeholders and maintain relationships with external partners, consulting firms and vendors.
• Drive medical devices design control compliance by ensuring that all applicable safety, quality and regulatory guidelines and policies are followed to develop safe and effective products.
  
  
  

Travel:

• Occasional (:10%) travel, domestic and international.
  
  
  

Qualifications

Work Environment:

• Mainly office in combination with limited laboratory and occasional manufacturing work environment
• At times will entail prolonged sitting in front of a computer.
• Willingness to adjust work schedule to meet the demands of the company including occasional non-business-hours.
  
  
  

Qualifications, Knowledge, Skills and Abilities:

• Hands-on experience with life science laboratory techniques and best practices is required
• Proficiency with biochemical and statistical methods associated with design of experiments and analytical methods is required
• Track record and experience relating to IVF Media products is preferred and will provide advantage
• Knowledge with MDR/MDD regulations and experience with ISO 10993 is strongly desirable
• Working knowledge of domestic and international regulations relating Class II and III Medical Devices is required
• Problem-solving, structured, risk-based and systematic approach
• Track record of project management activities is strongly desirable
• An outcome focused mindset including process discipline and drive for timely project completion.
• Excellent interpersonal and effective communication skills with internal and external stakeholders ranging from project engineers and consultants to key opinion leaders and executives.
  
  
  

Experience:

• 6+ years of relevant experience, depending on degree level, in product development, Sustaining engineering or relevant field within Medical Devices/Pharmaceutical Industry. Preferably in a scientist or engineering role.
• Experience in IVF Media or cell culture media products development & manufacturing is highly desirable
  
  
  

Education:

• Minimum Engineering, life science and/or clinical education background (B.A. or B.S).
• Preferred, graduate degree in relevant scientific field such as Biochemistry, analytical chemistry or Engineering.
  
  
  

As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.

To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace