Thisposition will encompass all aspects of the medical device product sourcing process, from the project concept phase through project management and vendor/product qualifications.
The engineer in this role will work to support legacy vendors/products (reusable surgical instruments) as well as new strategic supplier initiatives such as adding new suppliers and the phase-out of existing ones, product sample evaluation and approval in alignment with the Tuttlingen office lead. This role will also include working closely with cross functional team members, including quality, regulatory, product management, engineering and the supply chain group.
Assignments will usually include one or more of the following:
Direct support of the Managing Director with the implementation/provision of larger projects
Participation in the development of new suppliers
Qualification of new suppliers
Independently carry out sample assessments and prepare test reports using relevant standards and technical drawings
Further development of the existing supply base
Project surveillance and definition of needed action times
ESSENTIAL DUTIES/RESPONSIBILITIES:
Work with cross functional teams.
Work with the engineering team to implement needed change requests and initiation of vendor notification
Work with product management to clarify design deviations from current patterns (applicable for complex products)
Support of (new) sourcing initiatives such as adding new vendors, product transfers, dual-sourcing, phase outs
Assist in the evaluation of initial samples and redline drawings.
Update and maintain project lists with ongoing transfers and vendor phase-outs
KNOWLEDGE, SKILLS, AND ABILITIES:
Desired Knowledge of:
Strong product knowledge with reusable surgical instruments and their applicable standards
Expertise in the area of contract manufacturers for surgical instruments
Quality management knowledge in ISO 13485, MDR and FDA requirements
Desired Skills:
Strong organizational skills
Strong verbal, written English skills
Problem solving, technical understanding
Project management
Computer skills, including Word, Excel, and PowerPoint
Desired Abilities:
Self Motivated
Capable of managing a variety of assignments concurrently
Flexibility and adaptive to changes in the work environment, requirements, and assignments
Interface professionally and courteously with customers/public/internal staff
Meet goals and objectives set for the department and the company
EDUCATION AND EXPERIENCE
A completed Education (Technical or Commercial), Technician/Master Craftsmen or BA/BS in Medical Engineering.
Demonstrated understanding of various types of surgical instruments requirements, materials, tolerancing, drafting and testing standards required.
Minimum 3 years of Medical Device experience, mainly reusable surgical instruments
LOCATION: Tuttlingen, Germany
TRAVEL REQUIREMENTS: 0-15%
Aspen Surgical is an Equal Opportunity Employer M/W/V/D
Aspen Surgical is dedicated to developing and delivering high-quality, innovative surgical instruments that meet clinicians' needs and improve patients' lives. Our team collaborates with healthcare providers around the world to provide medical devices that exceed our customers' expectations and provide solutions for today's needs and tomorrow's growth. Our rich and diverse history creates one of the industry's most comprehensive surgical instrument portfolios, which includes our well-known brands such as BOOKWALTER®, GREENBERG®, OLSEN®, SYMMETRY®, SHARP KERRISON™, FLASH PAK®, CLASSIC®, CLASSIC PLUS®, SECTO®, QUAD-LOCK®, RAPIDCLEAN®, MIDAS TOUCH®, ULTRA INSTRUMENTS®, VersaPakTM, BOVIE® and TRANSPAK®.
INTENT AND FUNCTION OF JOB DESCRIPTIONS:
Requirements, skills, and abilities included have been determined to be the minimal standards required to successfully perform the positions. In no instance, however, should the duties, responsibilities, and requirements delineated be interpreted as all inclusive. Additional functions and requirements may be assigned by supervisors as deemed appropriate.
In accordance with Americans with Disabilities Act, it is possible that requirements may be modified to reasonably accommodate disabled individuals. However, no accommodations will be made which may pose serious health or safety risks to the employee or others or which impose undue hardships on the organization.
Job descriptions are not intended as and do not create employment contracts. This organization maintains its status as an at-will employer. Employees can be terminated for any reason not prohibited by law.
Karrierestufe
Management
Beschäftigungsverhältnis
Vollzeit
Tätigkeitsbereich
Ingenieurwesen
Branchen
Herstellung medizinischer Geräte
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