Mechanical Engineering Team Leader - Ecublens, Schweiz - Swiss ELS

Swiss ELS
Swiss ELS
Geprüftes Unternehmen
Ecublens, Schweiz

vor 4 Wochen

Lena Schneider

Geschrieben von:

Lena Schneider

beBee Recruiter
Beschreibung

_The Mechanical Engineering Team Leader is responsible for the development, testing, verification and validation of all mechanical parts of insulin patch pump.

The key goal is to successfully transfer the design to manufacturing after demonstration of reliability. She/he sets the direction and leads daily the mechanical engineering teams from pre-series to regulatory approval._


KEY SKILLS AND TEMPERAMENT:


  • Recognized as a leader, provides direction for the development of all mechanical functions.
  • Recognized experience in design for manufacturing and transfer into a manufacturing environment.
  • Real talent in micromechanical design.
  • Passionate about enhancing performance and reliability of innovative micromechanical medical system to delight users.
  • Keenly accountable to deliver ontime, onbudget work product that exceeds expectations.
  • Strong at making right technical decisions especially in a shortdeadline and fastpaced planning context.
  • Autonomous and proactive, with a team player mindset.

PRIMARY DUTIES & RESPONSIBILITIES:


  • Responsible for enhancing the reliability of the patch pump mechanical systems.
  • Work in close collaboration with the Electrical Engineering team.
  • Ensure successful and timely execution toward company goals, in close collaboration with the Electrical Engineering, Software Engineering, Manufacturing and QA/RA teams.
  • Oversee the daytoday operations of the Mechanical Engineering team including:
  • Motivate and manage staff: manage selection, development, performance evaluation, merit recommendation and promotion of team members.
  • Manage the planning of the design, development, modification and evaluation of parts, components, mechanical systems, equipment and packaging.
  • Work closely with the Electrical Engineering Team Leader to ensure integrated and overall consistent product functions.
  • Identify and manage suppliers and vendors required for the product development process.
  • Manage projects and activities in a multiple subproject environment with demanding schedules to coordinate staff, subcontractors and outsourced services.
  • Provide project planning and implementation updates to the executive team.
  • Negotiate with other departments as necessary and consider companywide impacts in decision making.
  • Ensure that team members are properly trained, in accordance with the designated training plan, prior to assuming job responsibilities.
  • Ensure that the department complies with company policies, including privacy and GDPR, and other legal and regulatory guidelines.
  • Participate to micromechanical systems risk analysis (both design and process FMEAs).
  • Other responsibilities as required.

REQUIRED QUALIFICATIONS:


1.
Knowledge, skills & abilities:


  • Expert in reliable mechanical design.
  • Strong experience in the design and development of mechanical medical devices, or automotive systems, from preseries to production and regulatory approval.
  • Demonstrated experience in industrialization and manufacturing processes capability.
  • Excellent knowledge of micromechanical assembly tolerancing.
  • Understanding of the mechanical medical device development process, including the regulatory approval process. Or experience in another highly regulated environment.
  • Advanced knowledge of Solidworks, use of surfaces and simulation tools an asset.
  • Innovative, results oriented and proactive attitude.
  • Strong organizational and time management skills.
  • Proven ability to work in a fastpaced, multiple priority environment.
  • Experience writing requirements and technical specifications.
  • Fluent in English and French preferred, German an asset.
  • Good knowledge of production techniques and automation is an asset.
  • Good knowledge of plastic injection, is an asset.

2.
Minimum certifications/educational level:


  • Master's degree in microengineering, mechanics, or equivalent.

3.
Minimum experience:


  • 15 years of combined experience in medical device industry or another regulated field.
  • Experience in leading teams.
  • Experience with product lifecycle from preseries to market followup.
  • Must have previous involvement in the development of a Class II or III electromechanical medical device. Including experience with development within an ISO 13485 certified QMS.
  • Experience with FDA validation of medical devices a plus.

SCOPE:


  • Has a wide range of experience and resolves complex issues in creative and effective ways.
  • Works on complex issues where analysis of situations or data requires an indepth evaluation of variable factors.
  • Determines methods and procedures on new assignments.

PHYSICAL REQUIREMENTS:


While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk, or hear in a standard office environment.

In a lab setting, occasionally use hands to finger, handl
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