Job Description

The Position

The Senior Specialist Medical Device and Combination Product (MDCP) engineer is a key technical leader of regulatory and quality system requirements within Organon. Under general direction, the engineer leverages experience gained on scientific/technical/business issues to support project teams and other technical staff in regard to design control, risk management, product development, and package development for medical devices, combination products, and pharmaceuticals. The person in this position participates in high impact, complex, cross-functional and cross-divisional teams and initiatives and will provide significant leadership to achieve project goals. Effective collaboration with teams is essential to meet Organon’s goals/objectives. Key interfaces include sites, External manufacturing, Quality Ops, Product Development groups, Regulatory Affairs, Procurement and suppliers.

Knowledge of design control, medical device, combination products, drug delivery, pharmaceuticals and related scientific/technical concepts and techniques are highly desirable for this position. The engineer will routinely face competing priorities, and must manage time effectively, while keeping stakeholders and team members informed with effective communication.

Responsibilities

• The engineer will be expected to build inclusive collaborative partnerships with internal and external stakeholders such as: Packaging Technology Operations, Commercial Marketing, Clinical Supply, Internal Manufacturing Sites, Contract Manufacturers, Analytical Testing, Quality Assurance, and Regulatory Affairs.

• Provide direction for selecting new product device and packaging components followed by establishing component specifications, test methods /validation as needed.

• Support equipment selection and line layout decisions for new product introductions.

• Actively supports and applies various initiatives and goals of Organon; including those for design control, risk management, change control, customer complaints and deviation management.

• Operates effectively as a leader in assigned roles on projects, or as Organon representative on multiple small teams.

• Displays ownership of tasks and continuously undertakes professional development activities to improve skills.

• Demonstrates the necessary inclusion skills to integrate inputs and perspectives from various sources and communicates the decision and its Risk/Benefit implications to key stakeholders and sponsors.

• Speaks/presents effectively to both internal and external audiences to influence change and build consensus.

Required Education, Experience and Skills

• Required: Technical Bachelor's of engineering degree or higher (MS).  

• Experience in the medical device, combination products, biologics and/or pharmaceutical industry.

• Experience in design control, risk management, product development, and package development for medical devices, combination products, and pharmaceuticals.

• Ability to complete all activities with the highest regard for all Organon procedures for safety, quality, and regulatory compliance.

• Excellent oral and written communication skills.

Preferred Education, Experience and Skills

• Bachelor's degree in mechanical engineering, biomedical engineering, materials engineering, packaging Sciences or similar.  

• Four years of experience in medical device, pharmaceutical or in biotech organizations.

• Experience with regulations for medical device or combination products.

• Experience with package development and distribution testing

• Experience leading and enabling diverse teams.

• Knowledge of sterile and non-sterile combination products.

• Knowledge of plastics, injection molding, equipment automation.

Secondary Language(s) Job Description

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

US and PR Residents Only

If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at staffingaadar@organon.com .

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

Organon proudly embraces diversity in all of its manifestations and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity, or gender expression, national origin, disability, veteran status or any other characteristic protected by state or federal law.

Search Firm Representatives Please Read Carefully

Organon LLC., does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Applicable to United States Positions Only: Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

Annualized Salary Range (US)

$92,400.00 - $157,100.00

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.

10%

Flexible Work Arrangements:

Remote Work, Telecommuting

Shift:

1st - Day

Valid Driving License:

Yes

Hazardous Material(s):

Number of Openings:

1

Requisition ID: R525385