Product Engineer

As a Product Engineer you will provide technical support to customer drug/device combination product development programs, in-house device manufacturing and Quality operations. This is a dynamic onsite position interacting with many departments. Duties will include but are not limited to:

Provide product technical support to cross-functional teams such as, but not limited to, Sales, R&D and Regulatory Affairs.

Conduct experimental studies (e.g. Simulations, DOEs) to support product investigations and customer development activities.

Provide risk analysis to support product-manufacturing activities.

Support managing product technical dossiers and ensure technical drawings are reviewed and current.

Participate in Client and /or key industry meetings.

Define product quality and performance requirements with the appropriate stakeholders in R&D.

Perform periodic trending of inspection and test data to ensure optimal product performance.

Support the creation of product line training materials.

Interface with Regulatory Affairs ensuring products meet regulations for US/Canada markets.

Manage assigned Corrective and Preventive Actions (CAPA).

Collaborate with global partners and product expert centers in France and Germany.

Monitor global production capabilities and provide technical support to Global manufacturing sites including leading product quality/production issues as well as supporting continuous improvement activities.

Qualifications

Bachelor's degree in Mechanical, Chemical or Plastic Engineering or equivalent experience .

2 years' experience in the product support or Quality Engineering in the realm of molding and assembly of high precision plastic components .

Pharmaceutical or Medical Device industries experience a plus .

Knowledge of Product failure/complaint investigations practices (Ex. RCA, QRQC)

Knowledge of statistical analysis techniques

Knowledge of ISO, CFR 21 regulations and GMPs .

Independent self-starter with excellent verbal and written communication skills.

Proficient with Microsoft Office (Excel, PowerPoint, Outlook) and MS Project.

Curiosity, initiative, self motivated