Senior Product Process Engineer-Medical Device

SUMMARY

Responsible for engineering activities (manufacturing and design engineering) associated with assigned product lines, including: process and product design-development, documentation, implementation, problem solving, maintenance, training and technology transfer, hands-on assistance, supervision.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES: include the following. Other duties may be assigned.

Maintain communication with manufacturing on established products concerning changes, revisions, problems and take necessary action.

Develop process and manufacturing documentation, prepare manufacturing operation records, prepare appropriate documentation such as operator manuals, maintenance logs, and Good Manufacturing Practice (GMP) records.

Supervise development technicians, toolmakers, and draftsmen on assigned projects, along with operational personnel as required.

Establish contacts with vendors and suppliers for services required.

Specify and order materials and components for prototype manufacturing.

Design and detail machine and tool components.

Train production and set-up personnel as required.

Interface with Original Equipment Manufacturers (OEM) customers as required.

Adhere to all company policies, rules, procedures, and housekeeping standards.

Provide other department and manufacturing support and provide feedback to supervisor immediate supervisor.

Create protocols and implement qualification/validation for product/process as required.

Manage complete programs through project management.

Provide product and process development through internal and external sources.

Assist in redesigning product for PMP manufacturing.

Provide customer communications as needed to implement new products and processes.

Assist in conducting training sessions with new employee orientation, on-the-job training as associated with assigned product line responsibility.

Solve maintenance problems and implement solutions as associated with assigned product lines.

Adhere to all Company policies, rules, procedures and housekeeping standards.             

Follows the official policy for Good Manufacturing Practices as required in the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act.

Provides feedback and pro-active communication to supervisor, management, and co-workers to ensure efficient and effective operations.  Contributes input to management based on knowledge of processes toward process and product improvement efforts of the company.

Provide other department and manufacturing support as requested by immediate supervisor.

Actively involved in the TQM efforts of the Company.

 

Other duties may be assigned.

 

SUPERVISORY RESPONSIBILITIES

Directly supervises 1 to 12 employees in the total operation.  Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws.  Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

 

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

EDUCATION and/or EXPERIENCE

Bachelor’s degree (BS) from four-year college or university; or fifteen years related experience and/or training; or equivalent combination of education and experience.

Apply today at Gage Personnel

  • Ephrata

    348 N. Reading Rd, Ephrata, PA

    Hours for applications are 8am-3pm Monday through Friday

    Call Katie at 717 336-5959 or send resume for immediate consideration to:

    Ephrataoffice@gagepersonnel.com

    We look forward to meeting with you!

 

 

Employment Type: 

Pay Rate: 

DOE

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