Sr. Product Transfer Engineer (Manufacturing)

Essential Responsibilities

Lead operational integration and validation strategy, planning and execution.
• Evaluate impact on manufacturing process due to changes in equipment, scale, and raw materials.
• Ensure the assembly of data for reports and other needed documents for regulatory submissions.
• Own the development of cross functional project plan for development and launch of new products.
• Assume ownership of meeting NPD scale-up deadlines by working around monthly finished goods demand.
• Quantify and/or qualify the impact of raw material vendor selection on NPD.
• Ensure relevant staff members are directly involved in core team meetings.
• Author and execute a statistically relevant validation plan.
• Ensure that all documentation is completed to pull new products into manufacturing.
• Assist in developing state-of-the-art design and simulation tools.
• Provide project management duties as needed, to include working effectively with cross functional teams.
• Facilitate designs through cross functional approval and change implementation.
• Develop test procedures, test plans and project schedules.
• Support the factory to ensure product build is completed per schedule with the highest quality.
• Support the field to provide technical recommendations to ensure any product issues are adequately resolved.
• Provide documentation for both production and disaster recovery procedures for each project, and take part in regular disaster recovery and business continuity tests.
• Actively shape the process development and ensure that all activities are completed and documented in accordance with the procedures.
• Coordinate with internal and external partners to solve technical challenges and implement efficient manufacturing and testing strategies in a highly technical environment.
• Make a significant contribution to the realization of short transfer times through innovative problem-solving methods, continuous development, and optimization of our manufacturing processes.
• Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product transfers.
• Protect long term viability of facility through effective management and growth of infrastructure via various cost saving projects.
• Reviews testing methodologies, equipment, documentation, etc. for appropriateness to demonstrate that conformance to established standards and/or specifications for all projects.
• Lead validation activities supporting manufacturing processes at multiple Erbe sites.
• Support internal/external audits and other lifecycle activities.

Supervisory Responsibility

This position does not have direct report responsibility.

Work Environment

This position operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. This position also works in manufacturing settings.

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.  While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk; use hands to finger, handle or feel; and reach with hands and arms.

Position Type and Expected Hours of Work

This is a full-time position. Days and hours of work are Monday through Friday, general business hours. Occasional evening and weekend work may be required as job duties demand.

Travel

This position requires occasional travel with some international travel included.

Required Education and Experience

• Bachelor's degree in engineering, science, or related area of study or equivalent years of experience
• 10+ years experience in the medical industry, quality systems, operational integrations, quality assurance, project management and regulatory affairs required.
• 10+years of experience in product transfer/development engineering, process engineering, supplier development/PPAP.
• Competence in applying and assuring compliance to QSR and MDD Requirements as well as ISO 9000 and EN 4600 series Standards (Includes interfacing with involved regulatory agencies such as FDA) required.
• In depth experience with complex, cross-functional business issues and operations.

Position Requirements

• Excellent verbal and written communications required; strong facilitation and interpersonal skills required.
• Thorough understanding of research and development, validations, quality, and regulatory are necessary with operations and quality systems auditing capabilities.
• Must be able to communicate complex information to all levels within the organization.
• Demonstrated high quality computer skills including MS Office, Outlook and some exposure to electronic quality systems.
• Must be detail-oriented and produce high quality work in a high volume environment.
• Must be able to handle confidential information in an appropriate and professional manner.

                                                                                                                                                                                                                                                                                                                      Competencies

• Problem Solving/Analysis
• Results Driven
• Detail Orientation
• Customer Focus
• Technical Capacity
• Communication Proficiency

Additional Eligibility Qualifications

None required for this position.

Work Authorization/Security Clearance

Employees must be legally authorized to work in the United States. Employees must not be specifically barred from working with Federal contracts, government entities or otherwise listed on excluded parties list as maintained by the Federal government.

AAP/EEO Statement

Erbe employees and applicants for employment are protected by federal laws, Presidential Executive Orders, and state and local laws designed to protect employees and job applicants from discrimination on the bases of race, religion, color, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, family medical history or genetic information, political affiliation, military service or other non-merit-based factors. These protections extend to all management practices and decisions, including recruitment and hiring practices, appraisal systems, promotions, and training and career development programs.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

At-Will Employment

This position description does not constitute a contract or guarantee employment for any specified time.  The company may exercise its employment-at-will rights at any time.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

See job description