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

Development of a programmable security door lock for hotel room access and corporate buildings with access rights for respective areas
Specification of plastic and zinc die-cast parts
Creation of test samples and presentation models using a 3D printer
Testing of 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

Development of novel valves for water regulation
Modeling individual parts and assemblies in plastics and metals using CAD
Performing tolerance calculations
Producing prototypes using a 3D printer
Deformation calculations of O-rings
Conducting tests on adjustable flow rates
Minimizing noise generation in pipelines 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

Development and documentation of various products in the field of cardiology
Product and process development, design concept, material selection, engineering
Ensuring cost-effective manufacturability
Maintenance and improvement of existing processes and technical process development
Analysis of project workflows and assessment of process risks
Preparation and execution of sample and prototype tests
Documentation according to regulatory and normative requirements
Tools: SolidWorks 2022, MS Office

Jun 2022 - Aug 2022

3 months

Eschborn, Germany

Development Engineer

Zühlke Engineering GmbH

Module development of a new defibrillator generation
Modeling and drawing derivation of plastic half-shells, PCB integration, tolerance calculations, FMEA
Application of 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

Creation of 'wetted parts lists' for product approval under the reduced lead content regulation in the USA
Analysis of metal alloys of all wetted parts in systems sold in the USA
Implementing bill of materials changes for replaced materials in SAP
Modifying drawings and preparing approval documents
Tools: SAP R3, MS Office, Catia V5, Catia V6

Mar 2021 - Jun 2021

4 months

Augsburg, Germany

Development Engineer

Plasmion GmbH

Developed an innovative high-performance odor sensor using the latest methods in chemical analysis
Tools: MS Office, SolidWorks 2019

Oct 2020 - Jan 2021

4 months

Nagold, Germany

Development Engineer

Nicolay GmbH

Developed a sensor cable for flow and pressure measurement in ventilation of preterm and newborn infants
Arranged sensors for pressure, temperature and flow in the ventilation area with integration into corresponding ventilators
Designed filtration of 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

Managed projects for new applications of UV rapid coating curing for matt-finish paints
Tools: MS Office, MS Project, Inventor, Annotation

Mar 2019 - Jun 2019

4 months

Therwil, Switzerland

Development Engineer

SenTec AG

Developed a new generation of devices for measuring blood oxygen levels
Designed a plastic housing with electrical connections and functional couplings to the main unit
Prepared and cleaned the sensor tip for measuring blood oxygen levels in the ear
Tools: Catia V6, MS Office, MS Project

Sep 2018 - Mar 2019

7 months

Heilbronn, Germany

R&D Engineer

Xenios AG

Developed a new generation of venous and arterial cannulas for use with oxygenators
Created requirements and specifications documents for functional components
Designed flow components and assemblies considering fluid mechanics requirements
Developed new manufacturing processes (plastic processing, adhesive and joining processes, metal and plastic bonding)
Coordinated and conducted prototype tests
Managed components from concept phase to series release
Prepared design documentation and researched new materials and technologies
Protected emerging 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

Creation, support and ensuring the functionality and lifespan of new injection molding tools for oxygenators
Support for oxygenators during the product lifecycle and optimization of product quality
Analysis of complaints and technical support for suppliers of new plastic injection molding tools
Checking 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

Development of a packaging concept for a phaco cassette in ophthalmic surgery
Design and assembly concept with cost calculations for 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

Relocation of surgical light production to a new site
Assembly analysis, optimization and creation of new specifications for FDA recertification according to MPG standards and P-FMEA
Identification and correction of production weaknesses and errors
Revision and management of drawings 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 sterilization instruments and devices
Creation and revision of medical instruments (forceps, tweezers, clamps) and sterilization equipment 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
Use 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

Development of the final design of an instrument set and approval documentation for an MIS lumbar spine product
Creation of test plans and rationales, execution of tests and test reports following risk analysis and FMEA
Preparation of acceptance tests in clinics
Support for 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

Development and design of tabletop and hot water systems with plastic parts manufactured in the Far East
Product variants in freeform surface design and functional mechanical assemblies
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

Development and design of implants and instruments for hip and spinal implants, including a minimally invasive lumbar spine implant
Conducting implant studies and evaluations on cadavers with medical teams
Conducting 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

Development and design of 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
Design and modeling of plastic and zinc die-cast parts according to DIN EN 60529 for touch and water ingress 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

Development, design, and simulation of 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 sales figures and complaint cases of implants from hospitals, surgeons and patients
Application of guideline 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 Manager Research and Development

Biedermann Motech GmbH & Co. KG

Responsible for custom and in-house development projects (intervertebral disc replacement implants, pedicle screw systems, posterior dynamic systems, femur anchors, Nitinol implants, PEEK cages, expandable cages, connectors)
Development of instrument sets for first use in surgery and cadaver studies
Support and documentation for CE and FDA approvals 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 Manager / Deputy Head of Development

U.T.S. Präzisionstechnik

Project management of radio-controlled and quartz movements, including 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 the management
Monitoring tool progress, creating test plans, approving parts and projects
Conducting design and process FMEAs
Analysis and preparation of test results
Tools: SolidWorks, CorelDraw, MS Office

Nov 2003 - Mar 2004

5 months

Sankt Georgen im Schwarzwald, Germany

Project Manager, Design and Development

Andreas Haller Fabrik für Feinmechanik GmbH & Co. KG

Design and development of clocks and display instruments for high-end vehicles (Porsche, Bentley)
Optimization of instrument and pointer lighting
Revision of bidirectional stepper motors
Design of injection-molded housings and functional parts (light-guiding pointers, displays, plastic-bonded magnets, gears, temperature gauges)
Conducting design FMEAs
Tools: SolidWorks, MS Office

Jan 2003 - Sep 2003

9 months

Schaffhausen, Switzerland

Development Engineer, Automotive Interior

TRIKON Solutions AG

3D modeling of complete assemblies in precision engineering
3D modeling of plastic parts for door and dashboard control elements in the automotive sector
Development of innovative project solutions and production of demanding 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 devices for nerve and muscle stimulation (TENS, EMS, INCO) up to series production
Optimization of air bubble baths with backflow prevention (patent filed)
Development and design of an AED (automated external defibrillator) with responsibility for mechanical components (housing parts, keypads, electrodes) considering cost, manufacturability, usability, and reliability
Optimization of wellness, home care, and electro-medical products
Approval of prototype parts, production parts, and finished products in the mechanical area
Performing 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 through series production
Tools: MS Office, AutoCAD

Jun 1995 - Mar 2000

4 years 10 months

Unterkirnach, Germany

Project Lead, Development and Design

Moser Elektrogeräte GmbH

Project leadership of several hair clippers, oral care products, and shavers
Value analysis studies to reduce costs in mass-produced hair clippers
Development of a dog detangling comb for animal coat care and sheep shearing machines
Development and project leadership of a low-cost hair clipper product line for Calor, Wahl, and Moser
Tool progress monitoring, tool approvals, parts and device approvals
Performing design and process FMEAs
Analysis and preparation of 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 special-purpose machines, automation systems, and feeding and sorting equipment
Tools: AutoCAD, MS Office

Jul 1986 - Sep 1994

8 years 3 months

Sankt Georgen im Schwarzwald, Germany

Development and Design

Schmidt Feintechnik GmbH

Developed writing instruments, dosing devices, and cosmetic products for Montblanc, Lamy, Pelikan, Tipp-Ex, and Artdeco
Contributed to patent applications in the field of writing and dosing device technology
Tools: HP-ME10

Mar 1985 - Jun 1986

1 year 4 months

Sankt Georgen im Schwarzwald, Germany

Development and Design

Tobias Baeuerle & Söhne

Developed a blood testing device
Designed planetary and bevel gears
Applied electronic and pneumatic controls, gearbox 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

Secondary Technical School Diploma · 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 Production 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 Precision 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 Project Management Manual of Biedermann Motech

Schrack & Partner

Solid Designer 3D Design, Part I

arxes

Solid Designer Advanced Course

arxes

Solid Designer Workshop Data Exchange

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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