Manufacturing Engineering Technician and Drafter

Job Summary:

The Manufacturing Engineer Technician will work closely with the company’s Product Development Team and outsourced manufacturing suppliers to create, improve, implement, and document processes and procedures to manufacture, package and label the company’s products.  The Manufacturing Engineer will also work closely with engineers to edit CAD models and create engineering drawings.

In the event of potential non-compliance with applicable standards or regulations (e.g. FDA QSRs, ISO 13485, or ISO14971), the employee has the authority to hold any product or QA/RA documentation from shipment or further processing.  The employee has the responsibility to report any instances to their direct supervisor or above.

The Manufacturing Engineer must at all times act and conduct company business in an honest, ethical and strictly legal manner, complying with the Code of Conduct, other company policies, the AdvaMed Code and all applicable laws and regulations, whether national, regional, state or local. This individual is encouraged, expected, and required to report any suspected violations of laws, regulations, the Code or any other Company policy, and all other suspected unethical behavior. The company does not tolerate retaliation in connection with making good faith reports of suspected violations.

Job Responsibilities:

• Work with manufacturing and design engineers to translate CAD models and design intent into mechanical drawings.
• Edit engineering drawings based on manufacturer or product development feedback.
• Provide strong verbal and written skills in support of creation and development of work instructions, inspections documentation, change controls and visual aids as applicable.
• Collaborate with engineering and quality teams to assess the impact of specification changes. Document and communicate changes to relevant stakeholders.
• Collaborate with peers to design and develop supply chain manufacturing processes for new products, enhancements, product changes, and related fixtures and tooling that are consistent with zero defect level.
• Support Material Review Board (MRB) activities including disposition and root cause investigation of non-conforming materials.
• Participate through the project validation phases with transition to manufacturing operations which includes efficiency gains/improvements post-pre-product status (including tooling, fixtures, processes, and costs).
• Participate in cross-functional teams with a focus on product packaging technologies, testing, validations, and labeling with Bar Coding and use of GTINs (Global Trade Identification Numbers).
• Assist in the evaluation of returned materials/products.
• Support and adhere to company policies, procedures, goals and objectives, QSR/FDA regulations, and evaluate suppliers for good manufacturing practices.

• This position requires travel to supplier facilities to observe and evaluate supplier manufacturing and assembly processes.
• Perform other duties that may be assigned as necessary.
• Support the company’s Quality System.

Qualifications/Experience:

• Strong SolidWorks and geometric dimensioning and tolerancing knowledge. SolidWorks PDM user and workflow programming experience a plus.
• Experience with Engineering Change Orders routing and approval processes related to specification updates, design improvements, and documentation updates.
• Ability to perform analyses to determine the feasibility of designs. FEA (ANSYS) knowledge a plus.