Gerhard P. - Diploma Engineer (FH), General Precision Engineering

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Sankt Georgen, Germany

Experience

Jan 2024 - Jul 2024

7 months

Affing, Germany

Development Engineer

ABUS Security Center GmbH & Co. KG

Developed a programmable security door lock for hotel room access and company buildings with access rights for respective areas
Specified plastic and zinc die-cast parts
Produced test samples and presentation models using a 3D printer
Tested samples and prototypes for functionality
Tools: SolidWorks 2021, SolidWorks PDM, MS Office, MS Project

Jun 2023 - Dec 2023

7 months

Müllheim, Germany

Development Engineer

Neoperl GmbH

Designed innovative valves for water regulation
Modeled parts and assemblies in plastics and metals using CAD
Performed tolerance calculations
Created prototypes using a 3D printer
Conducted deformation calculations for O-rings
Carried out tests for adjustable flow rates
Reduced noise generation in piping systems of multi-family houses
Tools: SolidWorks 2020/2022, MS Office, O-ring calculation software

Mar 2023 - Jun 2023

4 months

Rheinfelden, Germany

Development Engineer

Osypka AG

Developed and documented various products in the cardiology field
Product and process development, concept design, material selection, engineering
Ensured economic manufacturability
Maintained and improved existing processes and performed technical process development
Analyzed project workflows and assessed process risks
Prepared and conducted sample and prototype tests
Documented according to regulatory and normative requirements
Tools: SolidWorks 2022, MS Office

Jun 2022 - Aug 2022

3 months

Eschborn, Germany

Development Engineer

Zühlke Engineering GmbH

Developed a module for a new defibrillator generation
Modeled and prepared drawings for plastic half-shells, integrated PCBs, performed tolerance calculations and FMEA
Applied standards for module testing: DIN EN 1789, DIN EN 13718, DIN EN 60529, DIN EN 60601, DIN EN 60664, DIN EN ISO 20457, DIN EN ISO 14971, DIN EN ISO 13485
Tools: SolidWorks 2020, Pro.File, MS Office

Jan 2022 - May 2022

5 months

Schiltach, Germany

Project Engineer

Hansgrohe GmbH

Created 'wetted parts lists' for the product reapproval under the reduced lead content regulation in the USA
Analyzed metal alloys of all water-contacting parts in systems sold in the USA
Made bill of materials changes for replaced materials in SAP
Updated drawings and prepared approval documents
Tools: SAP R3, MS Office, CATIA V5, CATIA V6

Mar 2021 - Jun 2021

4 months

Augsburg, Germany

Development Engineer

Plasmion GmbH

Development of a novel high-performance odor sensor using the most advanced methods in chemical analysis
Tools: MS Office, SolidWorks 2019

Oct 2020 - Jan 2021

4 months

Nagold, Germany

Development Engineer

Nicolay GmbH

Development of a sensor cable for flow and pressure measurement in the ventilation of preterm and full-term infants
Arrangement of sensors for pressure, temperature, and flow in the ventilation area with integration into the corresponding ventilators
Development of filtration for germs and bacteria in the sensor channels
Tools: MS Office, MS Project, SolidWorks, AutoCAD

Aug 2019 - Oct 2019

3 months

Nürtingen, Germany

Project Manager

IST Metz GmbH

Project coordination of new applications of UV rapid coating curing for matte finishes
Tools: MS Office, MS Project, Inventor, Annotation

Mar 2019 - Jun 2019

4 months

Therwil, Switzerland

Development Engineer

SenTec AG

Development of a new generation of devices for measuring blood oxygen levels
Design of a plastic housing with electrical connections and functional couplings to the main unit
Preparation and cleaning of the ear probe for measuring blood oxygen levels
Tools: Catia V6, MS Office, MS Project

Sep 2018 - Mar 2019

7 months

Heilbronn, Germany

R&D Engineer

Xenios AG

Development of a new generation of venous and arterial cannulas for use with oxygenators
Creation of requirements and specification documents for functional components
Design of fluid flow components and assemblies, considering fluid mechanics requirements
Development of new manufacturing processes (plastic processing, bonding and joining processes, metal and plastic connections)
Coordination and execution of prototype tests
Support of components from the concept phase through to production release
Preparation of design documentation and research on new materials and technologies
Protection of resulting intellectual property
Tools: SolidWorks 2017, MS Office, EPDM management system, Project Place

Nov 2017 - Aug 2018

10 months

Hechingen, Germany

Life Cycle Engineer

Maquet Cardiopulmonary GmbH

Development, supervision, and ensuring of functions and lifespan of new injection molding tools for oxygenators
Support of oxygenators across the product life cycle and optimization of product quality
Analysis of complaints and technical support of suppliers in the area of new plastic injection molding tools
Verification of CAD 3D data and drawings, performing tolerance calculations
Tools: SolidWorks 2017, SAP R3, MS Office, MS Project, file system

Sep 2017 - Oct 2017

2 months

Oberkochen, Germany

Freelance development and design engineer

Carl Zeiss Meditec AG

Creation of a packaging concept for a Phaco cassette in eye surgery
Design and assembly concept with calculations for the units: blister, drainage bag, tubing, labeling
Tools: SolidWorks, MS Office

Apr 2017 - Aug 2017

5 months

Puchheim, Germany

Freelance development engineer

Trumpf Medizin Systeme GmbH & Co. KG

Production relocation of surgical lights to a new site
Assembly analysis, optimization, and creation of new specifications for FDA recertification according to German Medical Device Act standards and P-FMEA
Optimization of weak points and errors in production
Revision and management of the drawing documentation for surgical lights
Tools: Inventor, AutoCAD, SAP R3, MS Office, MS Project, Product Stream

Dec 2016 - Mar 2017

4 months

Mühlheim an der Donau, Germany

Freelance development and design engineer

Karl Leibinger Medizintechnik GmbH & Co. KG

Development and design of instruments and devices for sterilization technology
Creation and revision of medical instruments (forceps, tweezers, clamps) and sterilization devices in 3D and 2D for production transfers to Malaysia
Tools: SolidWorks 2016, MS Office, SAP R3, EPDM

Aug 2016 - Nov 2016

4 months

Böblingen, Germany

Freelance development and design engineer, regulatory documentation

Philips Medizin Systeme Böblingen GmbH

Creation and modification of technical 3D models and 2D drawings in .ai and .mi formats
Implementation of the UDI standard for human-readable and GS1 barcode formats
Application of ME10/One Space Drafting (2D) and Creo/ProE (3D) based on FDA requirements
Tools: HP-ME10, Creo Elements, MS Office, eDMR

Apr 2016 - Jul 2016

4 months

Tuttlingen, Germany

Freelance development and design engineer, regulatory documentation

B. Braun Aesculap AG

Developed final design of an instrument set and approval documents for a MIS lumbar spine product
Created test plans and rationales, carried out tests and reports based on risk analysis and FMEA
Prepared acceptance tests in clinics
Supported CE and FDA approval documentation, design/product FMEA
Tools: Catia V5, CDI, SAP R3, MS Office, MS Project

Nov 2015 - Mar 2016

5 months

Taunusstein, Germany

Freelance development and design engineer

BRITA GmbH

Designed and developed tabletop and hot water systems with plastic parts manufactured in the Far East
Created product versions with free-form surface design and functional mechanical units
Tools: SolidWorks, PDM-Pro.File, MS Office, MS Project

Jun 2015 - Oct 2015

5 months

Leinfelden-Echterdingen, Germany

Development and design engineer

Silony-Medical GmbH

Developed and designed implants and instruments for hip and lumbar spine minimally invasive surgery
Conducted implant studies and evaluations on cadavers with medical teams
Performed design FMEAs
Tools: SolidWorks, PDM-DB Works, MS Office, MS Project

Mar 2015 - May 2015

3 months

Leinfelden-Echterdingen, Germany

Development and design engineer

Euchner GmbH & Co. KG

Developed and designed plastic parts for a new multifunctional gate safety box according to DIN EN 60601
New development of the MGB module (Modular Gate Box) and a specific switching module
Designed and modeled plastic and zinc die-cast parts according to DIN EN 60529 for touch and sealing protection
Tools: SolidWorks, PDM-Phoenix, MS Office, MS Project

Oct 2014 - Feb 2015

5 months

Villingen-Schwenningen, Germany

Freelance development and design engineer

Barigo Barometerfabrik GmbH

Developed, designed, and simulated an altimeter mechanism in a wristwatch format for mountaineers
Tools: SolidWorks, MS Office

Jun 2014 - Sep 2014

4 months

Winterthur, Switzerland

Freelance Temporary Development Engineer R&D Hip

Zimmer GmbH

Revision of Design History Files for product traceability in traceability matrices of hip stems according to 93/42-MDD for FDA approvals
Tools: MS Office, MS Project

Feb 2014 - May 2014

4 months

Zuchwil, Switzerland

Freelance Temporary PD Engineer R&D Trauma

DePuy Synthes GmbH

Consultant in risk management for hand implants: sales & complaints
Collection and documentation of implant sales figures and complaint cases from clinics, surgeons and patients
Application of Directive 93/42-MDD for FDA approvals
Revision of Design History Files for FDA approvals
Tools: MS Office, MS Project

Apr 2006 - Mar 2013

7 years

Villingen-Schwenningen, Germany

Project Lead Research and Development

Biedermann Motech GmbH & Co. KG

Responsible for customer-specific and in-house development projects (disc replacement implants, pedicle screw systems, posterior dynamic systems, femoral anchoring devices, nitinol implants, PEEK cages, expandable cages, connectors)
Development of instrument sets for first-time surgeries and cadaver studies
Support and documentation for CE and FDA approval according to DIN 14971, DIN 13485, DIN 10993, MDD 93/42/EEC, FDA 21 CFR 820
Conducting design and process FMEAs
Collaboration with spine surgeons on clinical evaluations and project launches
Anatomical/biomechanical studies on cadavers and lumbar explants (Lucerne, Miami, Chicago)
Workshops on sawbone models
Contribution to patent applications
Tools: SolidWorks, CosmosWorks, Ansys, CorelDraw, Xara, Majesty, MS Office, MS Project

Apr 2004 - Mar 2006

2 years

Hardt, Germany

Project Management / Deputy Head of Development

U.T.S. Präzisionstechnik

Project management of radio-controlled and quartz movements as well as radio wall clocks, radio alarm clocks and radio wristwatches
Independent handling of large watch orders for Tchibo from initial sampling to delivery in China (Hong Kong, Shenzhen)
Reporting to executive management
Monitoring tool progress, creating test plans, approving parts and projects
Conducting design and process FMEAs
Analysis and processing of test results
Tools: SolidWorks, CorelDraw, MS Office

Nov 2003 - Mar 2004

5 months

Sankt Georgen im Schwarzwald, Germany

Project Management, Design and Construction

Andreas Haller Fabrik für Feinmechanik GmbH & Co. KG

Development and design of watches and display instruments for premium vehicles (Porsche, Bentley)
Optimization of instrument and indicator lighting
Revision of bidirectional stepper motors
Mold design for injection-molded housings and functional parts (light-guiding hands, displays, plastic-bonded magnets, gears, temperature sensors)
Conducting design FMEAs
Tools: SolidWorks, MS Office

Jan 2003 - Sep 2003

9 months

Schaffhausen, Switzerland

Development Engineer, Automotive Interior

TRIKON Solutions AG

3D designs of complete assemblies in the precision engineering field
3D design of plastic parts for door and dashboard switch elements in the automotive sector
Development of innovative project solutions and manufacturing of sophisticated prototypes
Tools: CATIA V4, MS Office

Oct 2000 - Dec 2002

2 years 3 months

Rottweil, Germany

Project Lead, Development and Design

Metrax GmbH

Development and design of nerve and muscle stimulation devices (TENS, EMS, INCO) through to production readiness
Optimization of air-jet baths with water backflow prevention (patent application)
Development and design of an AED (automatic external defibrillator) with responsibility for mechanical components (enclosure parts, keypads, electrodes), considering cost, manufacturability, usability and reliability
Optimization of wellness, homecare and electro-medical products
Approval of prototype parts, production parts and finished products in the mechanical area
Conducting design and process FMEAs
Tools: HP-ME10, HP Solid Designer, MS Office, MS Project, SAP R3

Apr 2000 - Sep 2000

6 months

Niedereschach, Germany

Product Manager

Johs. Förderer Söhne GmbH & Co. KG

Product management of various magnetic coils from concept to production
Tools: MS Office, AutoCAD

Jun 1995 - Mar 2000

4 years 10 months

Unterkirnach, Germany

Project Lead, Development and Design

Moser Elektrogeräte GmbH

Project lead for several hair clippers, oral care products and electric shavers
Value analysis studies for cost reduction of mass-produced hair clippers
Development of a dog detangling comb for pet grooming and sheep shearing machines
Development and project lead of a hair clipper product line in the low-price segment for Calor, Wahl and Moser
Monitoring tool progress, tool approvals, parts and device approvals
Conducting design and process FMEAs
Analyzing and compiling test results
Tools: Euclid-IS, Unigraphics V14, SAP R2, MS Office

Oct 1994 - May 1995

8 months

Sankt Georgen im Schwarzwald, Germany

Freelance Development Engineer

Technologiezentrum

Development of custom machinery, automation systems, and feeding and sorting equipment
Tools: AutoCAD, MS Office

Jul 1986 - Sep 1994

8 years 3 months

Sankt Georgen im Schwarzwald, Germany

Design and Development

Schmidt Feintechnik GmbH

Development of writing instruments, dosing devices and cosmetic products for Montblanc, Lamy, Pelikan, Tipp-Ex, Artdeco
Collaborated on patent specifications for writing and dosing device technology
Tools: HP-ME10

Mar 1985 - Jun 1986

1 year 4 months

Sankt Georgen im Schwarzwald, Germany

Design and Development

Tobias Baeuerle & Söhne

Development of a blood analysis device
Development of planetary and bevel gears
Application of electronic and pneumatic controls, gear technology, motor controls, optoelectronics and pneumatics

Languages

German

Native

English

Intermediate

Education

Oct 1979 - Jan 1985

Furtwangen University of Applied Sciences

Diploma Engineer (FH) · General Precision Engineering · Furtwangen, Germany

Aug 1977 - Jun 1979

Technical High School Stuttgart

University of Applied Sciences Entrance Qualification · Stuttgart, Germany

Sep 1972 - Jul 1974

Technical High School Stuttgart

Technical College Entrance Qualification · Stuttgart, Germany

...and 1 more

Certifications & licenses

Biological Safety Of Medical Devices

Medical Device Services

Use of Plastics in Medical Technology

TÜV Süd

Appointment as Medical Device Consultant under §31 MPG

Biedermann Motech

Euclid-3 Surfaces

ISTEC GmbH

Euclid-3 Freeform Surfaces

BINDE TRAINING

Euclid-3 Basics and Drawing Creation

BINDE TRAINING

Advanced Training for Project Team Leaders

IP – Industrielle Psychologie

Basics of Quality Management for Medical Device Manufacturing EN ISO 13485

Schrack & Partner

Kaizen Gemba Workshop

Institut Für Managementtraining Köln

Medical Device Consultant and Safety Officer under §30 and §31 MPG

Schrack & Partner

MS – Outlook 2010 for Users, MS – Office 2010 Update Training

Via Ventus GmbH

Optimal Injection Molded Parts

Süddeutsches Kunststoffzentrum Würzburg

Project Management in Medical Technology

Schrack & Partner

Risk Management EN 14971

Schrack & Partner

Risk Management for Medical Devices according to DIN EN ISO 14971

Eurospec

Training on the Biedermann Motech Project Management Manual

Schrack & Partner

Solid Designer 3D Modeling, Part I

arxes

Solid Designer Advanced

arxes

Solid Designer Data Exchange Workshop

arxes

SolidWorks 2008 Assembly Modeling

Solid Line AG

SolidWorks 2008 Advanced Part Modeling

Solid Line AG

SolidWorks in Application with Xara Basics

Injection Molding of Technical Precision Parts from Thermoplastics

Technische Akademie Esslingen

Unigraphics V14 Hybrid Modeling

Unigraphic Solutions

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