Senior Developer

Job Description (Posting).

Job Title

LocationMFG Equipment Validation Engineer

Warshaw, IN

Job Description

(Define At least 6 points which candidate is supposed to do)

• Knowledge in Program development process
• Familiar with Good

Documentation Practices (GDP)

• Familiar with GAMP Principles including

Lifecycle V Model.

• Experience with Windows Form application

And UI/UX design experience

• User Requirements Specification (URS),

Functional Requirements Specification (FRS) Traceability Matrix (TM), Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT),

Installation Qualification Protocol (IQP),

Operational Qualification Protocol (OCP),

Performance Qualification Protocol (PQP),

Process Validation Protocol (PV)

• SQL server database management

Experience

• Drafting and formalizing Process

Documentation (Manufacturing Process

Specifications (MPS),

Job Breakdown Sheets (JBS),

Product Inspection Criteria (PIC)

• Software Validation including but not

limited to generation of software

deliverables including Functional

Specification, Design Specification,

Module Specification and associated testing scripts and protocols to verify requirements specified are met.

• Vision system experience- Cognex.
• Windchill PLM system.
• GD&T, SPC, cp/cpk process

Capability studies

• Experience in PLC, programming.
• 21 CFR 820 medical device regulations
• 21 CFR 830 UDI requirements
• DFM principles, 2D-CAD, 3D models

Experience, Rapid prototyping /3D printing

Experience.

KEY COMPETENCIES REQUIRED:

• High Attention to Detail

Pro-active approach to Work

• High Standards
• Flexible
• Excellent Communication Skills
• Analytical Skills
• Team Player
• High level of Numeracy

Computer Literate

QUALIFICATIONS & EXPERIENCE

ESSENTIAL:

• QMS/CAPA/PFMEA/
• Proficient in set-up and operation of inspection equipment
• Proficient in metrology methods/technology
• Proficient in reading/interpreting engineering drawings and the application of Geometric Dimensioning & Tolerancing (GD&T) per ASME Y14.5
• Geometry & Trigonometry
• Proficient in Microsoft Word & Excel.
• Excellent interpersonal & communication skills
• Knowledge of mechanical inspection methods and tools used to determine product acceptance
• Ability to investigate and learn new technologies within metrology

DESIRABLE:

• Certificate / Diploma / Degree in Quality / Manufacturing / Engineering
• 21 CFR 11 and European regulations associated with the medical device industry
• High understanding of GMP
• Working knowledge of Quality Systems (FDA/ISO) within a regulated environment.

Familiarity with statistical analysis software

Job Description (Posting).

Job Title

LocationMFG Equipment Validation Engineer

Warshaw, IN

Job Description

(Define At least 6 points which candidate is supposed to do)

• Knowledge in Program development process
• Familiar with Good

Documentation Practices (GDP)

• Familiar with GAMP Principles including

Lifecycle V Model.

• Experience with Windows Form application

And UI/UX design experience

• User Requirements Specification (URS),

Functional Requirements Specification (FRS) Traceability Matrix (TM), Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT),

Installation Qualification Protocol (IQP),

Operational Qualification Protocol (OCP),

Performance Qualification Protocol (PQP),

Process Validation Protocol (PV)

• SQL server database management

Experience

• Drafting and formalizing Process

Documentation (Manufacturing Process

Specifications (MPS),

Job Breakdown Sheets (JBS),

Product Inspection Criteria (PIC)

• Software Validation including but not

limited to generation of software

deliverables including Functional

Specification, Design Specification,

Module Specification and associated testing scripts and protocols to verify requirements specified are met.

• Vision system experience- Cognex.
• Windchill PLM system.
• GD&T, SPC, cp/cpk process

Capability studies

• Experience in PLC, programming.
• 21 CFR 820 medical device regulations
• 21 CFR 830 UDI requirements
• DFM principles, 2D-CAD, 3D models

Experience, Rapid prototyping /3D printing

Experience.

KEY COMPETENCIES REQUIRED:

• High Attention to Detail

Pro-active approach to Work

• High Standards
• Flexible
• Excellent Communication Skills
• Analytical Skills
• Team Player
• High level of Numeracy

Computer Literate

QUALIFICATIONS & EXPERIENCE

ESSENTIAL:

• QMS/CAPA/PFMEA/
• Proficient in set-up and operation of inspection equipment
• Proficient in metrology methods/technology
• Proficient in reading/interpreting engineering drawings and the application of Geometric Dimensioning & Tolerancing (GD&T) per ASME Y14.5
• Geometry & Trigonometry
• Proficient in Microsoft Word & Excel.
• Excellent interpersonal & communication skills
• Knowledge of mechanical inspection methods and tools used to determine product acceptance
• Ability to investigate and learn new technologies within metrology

DESIRABLE:

• Certificate / Diploma / Degree in Quality / Manufacturing / Engineering
• 21 CFR 11 and European regulations associated with the medical device industry
• High understanding of GMP
• Working knowledge of Quality Systems (FDA/ISO) within a regulated environment.

Familiarity with statistical analysis software

Job Description (Posting).

Job Title

LocationMFG Equipment Validation Engineer

Warshaw, IN

Job Description

(Define At least 6 points which candidate is supposed to do)

• Knowledge in Program development process
• Familiar with Good

Documentation Practices (GDP)

• Familiar with GAMP Principles including

Lifecycle V Model.

• Experience with Windows Form application

And UI/UX design experience

• User Requirements Specification (URS),

Functional Requirements Specification (FRS) Traceability Matrix (TM), Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT),

Installation Qualification Protocol (IQP),

Operational Qualification Protocol (OCP),

Performance Qualification Protocol (PQP),

Process Validation Protocol (PV)

• SQL server database management

Experience

• Drafting and formalizing Process

Documentation (Manufacturing Process

Specifications (MPS),

Job Breakdown Sheets (JBS),

Product Inspection Criteria (PIC)

• Software Validation including but not

limited to generation of software

deliverables including Functional

Specification, Design Specification,

Module Specification and associated testing scripts and protocols to verify requirements specified are met.

• Vision system experience- Cognex.
• Windchill PLM system.
• GD&T, SPC, cp/cpk process

Capability studies

• Experience in PLC, programming.
• 21 CFR 820 medical device regulations
• 21 CFR 830 UDI requirements
• DFM principles, 2D-CAD, 3D models

Experience, Rapid prototyping /3D printing

Experience.

KEY COMPETENCIES REQUIRED:

• High Attention to Detail

Pro-active approach to Work

• High Standards
• Flexible
• Excellent Communication Skills
• Analytical Skills
• Team Player
• High level of Numeracy

Computer Literate

QUALIFICATIONS & EXPERIENCE

ESSENTIAL:

• QMS/CAPA/PFMEA/
• Proficient in set-up and operation of inspection equipment
• Proficient in metrology methods/technology
• Proficient in reading/interpreting engineering drawings and the application of Geometric Dimensioning & Tolerancing (GD&T) per ASME Y14.5
• Geometry & Trigonometry
• Proficient in Microsoft Word & Excel.
• Excellent interpersonal & communication skills
• Knowledge of mechanical inspection methods and tools used to determine product acceptance
• Ability to investigate and learn new technologies within metrology

DESIRABLE:

• Certificate / Diploma / Degree in Quality / Manufacturing / Engineering
• 21 CFR 11 and European regulations associated with the medical device industry
• High understanding of GMP
• Working knowledge of Quality Systems (FDA/ISO) within a regulated environment.

Familiarity with statistical analysis software

Job Description (Posting).

Job Title

LocationMFG Equipment Validation Engineer

Warshaw, IN

Job Description

(Define At least 6 points which candidate is supposed to do)

• Knowledge in Program development process
• Familiar with Good

Documentation Practices (GDP)

• Familiar with GAMP Principles including

Lifecycle V Model.

• Experience with Windows Form application

And UI/UX design experience

• User Requirements Specification (URS),

Functional Requirements Specification (FRS) Traceability Matrix (TM), Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT),

Installation Qualification Protocol (IQP),

Operational Qualification Protocol (OCP),

Performance Qualification Protocol (PQP),

Process Validation Protocol (PV)

• SQL server database management

Experience

• Drafting and formalizing Process

Documentation (Manufacturing Process

Specifications (MPS),

Job Breakdown Sheets (JBS),

Product Inspection Criteria (PIC)

• Software Validation including but not

limited to generation of software

deliverables including Functional

Specification, Design Specification,

Module Specification and associated testing scripts and protocols to verify requirements specified are met.

• Vision system experience- Cognex.
• Windchill PLM system.
• GD&T, SPC, cp/cpk process

Capability studies

• Experience in PLC, programming.
• 21 CFR 820 medical device regulations
• 21 CFR 830 UDI requirements
• DFM principles, 2D-CAD, 3D models

Experience, Rapid prototyping /3D printing

Experience.

KEY COMPETENCIES REQUIRED:

• High Attention to Detail

Pro-active approach to Work

• High Standards
• Flexible
• Excellent Communication Skills
• Analytical Skills
• Team Player
• High level of Numeracy

Computer Literate

QUALIFICATIONS & EXPERIENCE

ESSENTIAL:

• QMS/CAPA/PFMEA/
• Proficient in set-up and operation of inspection equipment
• Proficient in metrology methods/technology
• Proficient in reading/interpreting engineering drawings and the application of Geometric Dimensioning & Tolerancing (GD&T) per ASME Y14.5
• Geometry & Trigonometry
• Proficient in Microsoft Word & Excel.
• Excellent interpersonal & communication skills
• Knowledge of mechanical inspection methods and tools used to determine product acceptance
• Ability to investigate and learn new technologies within metrology

DESIRABLE:

• Certificate / Diploma / Degree in Quality / Manufacturing / Engineering
• 21 CFR 11 and European regulations associated with the medical device industry
• High understanding of GMP
• Working knowledge of Quality Systems (FDA/ISO) within a regulated environment.

Familiarity with statistical analysis software