Job Description

PRIMARY RESPONSIBILITIES:

·Communicates to management and internal cross functional team members of the status of assigned product development projects.

· Authors SOPs, work instructions, specifications, job packets, validation protocols (IQ, OQ, PQ) and other product development documents.

· Explores new designs and technology for single-use systems, explaining technical concepts to project stakeholders.

· Documents activities, experiments, trials, samples and ideas, protecting Intellectual Property (IP) and trademarks.

· Responsible for design of process that is scalable to a production environment based on client design and volume requirements.

· Leads a cross-functional team to facilitate a transition of product design and development to manufacturing.

· Communicates product development status, expectations, and constraints internally and externally.

· Responsible for documenting all phases of design control process and quality compliance.

· Partners with quality and operations to develop and perform verification and validation activities for equipment and production processes.

· Performs engineering risk assessment and participates in other risk management activities.

· Performs other job-related responsibilities as assigned.

REQUIREMENTS:

· Bachelor’s degree in industrial or mechanical engineering, or equivalent.

· Two years related experience in a regulated environment.

· Experience working in an ISO 13485 and 21 CFR 820 environment.

· Excellent verbal and written communication skills.

· Experience managing a technical project.

· Excellent interpersonal skills with proven ability to get along well with others and work in a team environment.

· Excellent analytical and problem-solving skills.

· Demonstrated organizational and decision-making skills.

· Knowledge of six sigma practices preferred.

· Experience in computer aided design, including AutoCAD or SolidWorks.

· Experience in technical writing and use of statistical tools, including Minitab.

Company Description

DemeTECH is a Medical Device Manufacturer exporting its product to over 100 Countries.