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Sustaining Engineer IV

CorTech LLC

This is a Full-time position in Acton, MA posted June 8, 2021.

Description:

Sustaining Engineer. The position is for a work stream lead who will be working with a cross-functional team to remediate legacy product documentation to meet update requirements put in place by MDR. This individual needs to be a self-starter, organized, and ideally has experience with technical writing, project management, EU-MDR requirements, STED files, risk management, and good documentation practices.

Skills: ERP experience (SAP preferred), Microsoft Office (Excel, Power Point, Word), Solidworks, SolidEdge (Nice to have).

Location: Acton,MA
Length of assignment: 3 months

JOB SUMMARY:
As a Project Leader in Sustaining Engineering, you will lead cross-functional Sustaining Engineering project teams to complete product branding transition projects from planning through implementation. This position is for someone who is goal driven and enjoys working in a dedicated cross-functional team environment.

An appropriate candidate must be a flexible, self-directed, organized, dependable, proactive, and persistent project leader. He or she must effectively plan and manage time and projects, solve problems, and make decisions with limited direction.

Specific project scope:
Allen Medical Systems, Inc. is in the process of finalizing the documentation required to be EU-MDR. This position will be directly involved with assisting the business in driving documentation remediation across the finish line.

Related project-based duties of the Sustaining Engineering Project Leader role include overall coordination and responsibility for execution of the following:
• EU-MDR technical documentation creation and corrections
• Update engineering drawings and product specification to meet new regulations
• Assist with Reach/RoHS compliance documentation
• Engineering Change Request to update and release documents and materials.
• Development and performance to project schedules

ESSENTIAL DUTIES & RESPONSIBILITIES

Primary responsibilities will be to effectively organize and lead cross-functional project teams using project management skills. Using your strong planning, organization, and collaboration skills, you will independently manage the projects with limited supervision.

Required Qualifications:

• Bachelor’s degree – Technical/Engineering Degree preferred
• At least 3 years of applied project management experience
• Applied experience with Office Suite applications
• Demonstrated ability to work with a diverse group of cross-functional stakeholders in Marketing, R&D, QA, Regulatory, Sourcing, and Operations.

Preferred Qualifications:
• Prior ERP (preferably SAP) experience including DIRs, BOMs, MMDS, and Engineering Changes
• Previous project management experience for similar project scope