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Senior Project Engineer

Job typeJob offer
A job for Professional experienced
We are looking for As of now
A job at Full time
Location

In the Röchling Group you’ll be shaping industry. Worldwide. Together, we are changing everyday lives – by making cars lighter, making drug packaging safer and enhancing industrial applications. With 11,000 employees in 25 countries.

In the Medical division, you will work with our customers to make pioneering contributions to disease prevention and health restoration worldwide. We offer a wide selection of custom-tailored components through to complete systems.

Your tasks:

The Senior Project Engineer is an experienced project manager and is accountable for overall project implementation activities. This leadership role requires a passionate and results-oriented person to be creative, technical, and analytical while utilizing advanced PM tools and processes in order to manage project activity and critical situations.

Job requirements:

Lead the planning and implementation of multiple, complex projects in a growing pipeline. Ensuring that projects stay within budgeting objectives. Must understand and be capable of managing billable hours, capital expenses and overall project costs.

Develop full scale project plans including detailed work breakdown structures and Gantt charts.

Work in close liaison with customer to assure positive customer experience and to achieve mutually beneficial results.

Support new product development initiatives via activities including process development, manufacturing sequence analysis, PFMEA/Quality planning requirements.

Design and/or implement improvements/new fixtures and equipment to support manufacturing processes.

Develop process and manufacturing documentation, manufacturing operation records, and associated process documentation such as preventive maintenance procedures, maintenance logs, and Good Manufacturing Practice (GMP) records.

Establish contacts with vendors and suppliers for services required.

Specify and order materials and components for process development and prototype manufacturing.

Assist with standard costing and quotations. Use MRP system to establish costing, bill of materials and operational routings.

Train production, set-up, and other personnel as required.

Complete project evaluations and assessment of results in the form of reports.

Provide technical support to define and continuously improve Engineering-related and Manufacturing processes.

Possess broad knowledge of manufacturing processes common to medical device manufacturing: injection molding, metal cannula processing, metal fabrication techniques, terminal sterilization (EO/Gamma), and packaging. Broad knowledge of medical device design controls and ISO Quality System practices.

Perform other projects and duties that may be assigned, as deemed necessary, by the supervisor.

SUPERVISORY RESPONSIBILITIES

Zero to four direct reports. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees, addressing complaints and resolving problems. As a team leader, the Senior Project Engineer will be expected to perform these same tasks with non-direct reports through constructive working relations with managers from other departments.

Basic Qualifications

Bachelor’s degree from an accredited college in a related Engineering discipline. Minimum 8 years of experience in a medical device process development and/or manufacturing environment. Two years of experience managing teams in a project manager (cost, schedule, risk) role. Cross functional project leadership experience.

Desired Skills

  • Experience with MS Project and other Microsoft® software such as Word, Excel, and PowerPoint
  • Experience with SolidWorks or similar CAD software
  • Experience with Medical Device Design Control
  • Experience with Regulatory standards specifically FDA 21CFR Section 820, ISO13485, ASTM and ANSI Standards as applicable
  • Effective written and verbal communication
  • Excellent interpersonal skills and proven ability to work in a fast-paced, dynamic environment
  • Experience with Lean Manufacturing and Six Sigma
  • Strong analytical, problem-solving, and negotiation skills
  • Strong customer focus
  • Ability to manage conflict

CERTIFICATES, LICENSES, REGISTRATIONS, OTHER SKILLS AND ABILITIES

Project Management Professional Certification (preferred)

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel and reach with hands and arms. The employee is frequently required to sit and talk or hear. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts and vibration. The employee is occasionally exposed to fumes or airborne particles and toxic or caustic chemicals. The noise level in the work environment is usually moderate.

Laura Poole
Human Resources
+1 717 335 3700
laura.poole@roechling-medical.us

Roechling Medical Lancaster
44 Denver Road
17517 Denver, PA
United States

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