at APN Software Services Inc.
This position is for a temporary contract engineer with expertise in injection molding, healthcare product manufacturing, and project management. This position can work remotely and/or on site, however being local to Glasgow, DE is preferred.
This individual will act as an injection molding technical expert with oversight responsibilities. The role will act as the project manager and technical lead to commission and qualify new injection molding assets at an upstream supplier. These assets will include molds, measurement systems, and automated inspection systems used for the manufacture of consumable components such as medical devices and laboratory equipment. The individual will interface with suppliers including molders, mold manufacturers, automation manufacturers, etc. Travel to/from suppliers and the Glasgow, DE site throughout the project is expected, with the opportunity to work from home when travel is not required. The role will have varying time commitment responsibilities, from zero to 40 hours per week, depending on project status.
The position will augment activities of the Glasgow Supplier Operations team by interfacing with suppliers on molded components such as cuvettes and pipettes to ensure compliance and to balance quality, delivery, and cost.
-Manages and coordinates all activities required to successfully relocate and validate injection mold tooling, associated automation, and test equipment.
-Ensures compliance with company's Healthineers' Quality Management System.
-Collaborates with suppliers and tool makers to meet or exceed business objectives.
-Works with project engineers to update and/or develops specifications, FMEA's, technical evaluations, and other technical documents.
-Some travel required.
Required Skills/ Knowledge:
-Strong project management acumen and communication skills.
-In-depth technical expertise with plastics, injection molding, and materials engineering, including robust understanding of injection molding process validations (IQ, OQ, PQC) required for FDA-regulated manufacturing.
-Demonstrated high level critical thinking and problem solving abilities with experience containing problems, conducting and documenting root cause, and identifying and executing solutions.
-Demonstrated ability to attain results while balancing technical solutions with business needs.
-Strong interpersonal skills with demonstrated ability to work across organizational boundaries, build networks, and collaborate in a team environment.
-Ability to act independently while managing complex and ambiguous tasks with minimal direction.
-Expertise in the use of Microsoft Project, Primavera, or similar Project Management platform and demonstrated ability to meet or exceed schedules.
Required Education and Experience:
-Bachelor of Science, at minimum, in relevant field such as Engineering, etc.
-Minimum 10 years experience.
Preferred Knowledge/Skills, Education, and Experience
-Expertise in navigating company's Healthineers’ Quality Management system or similar system.
-Experience working in FDA regulated environment.
-Experience working with products used in diagnostic or analytical laboratories.
-Experience managing suppliers.
-Experience collaborating with chemists and chemical engineers.
-Strong working knowledge of statistics and design for manufacturing.
Qualified Applicants must be legally authorized for employment in the Unites States. Qualified Applicants will not require employer sponsored work authorization now or in the future for employment in the United States.
As a VEVRAA Federal Contractor, APN Software is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. APN complies with applicable state and local laws governing nondiscrimination in employment.