Medical Device Project Manager

SCOTT M. JOHNSON P.E.

***** *********** **** ( Minneapolis, MN 55433 763-***-**** (

abhiah@r.postjobfree.com

PROFESSIONAL ENGINEERING LEADER

~ Significant Experience Leading the Development of New Products,

Processes, Systems and Regulatory Compliance ~

Accomplished leader of technical and functional staff personnel, capital

projects, quality and safety initiatives, and regulated environment

compliance. Sustains a culture that is ethical, profitable, positive and

creative.

. Cross-functional collaboration

. Scope, schedule, budget control

. Supply chain optimization

. Failure modes analysis

. Technical transfer leadership

. Process controls & specifications

Program Manager: Harland Medical Systems

2010 - 2011

Managed process design optimization programs. Focus was next generation

hydrophilic and antimicrobial surface enhancement processes and capital

equipment for implantable and transdermal biomedical devices. Led

stakeholders through project requirements, software verification, system

validation and commissioning.

. Defined the scope, schedule, process, assembly, resource requirements

and quality testing systems.

. Identified and implemented technology improvements and documented

intellectual property opportunities.

. Authored and executed the scope control and quality documents for

clean room capital equipment.

. Developed consistent documentation for functional and design

specifications, quality and validation efforts.

. Led supply chain refinement, vendor quality improvement, scrap

reduction and ECO standardization.

Product Engineering Team Leader: Johnson &

Johnson (Cordis) 2009

Leader of consulting efforts to develop coronary stent catheter delivery

system product specifications and build processes. The NEVO pharmaceutical

eluting stent focus was for European use and US clinical trials.

. Technical leader for a consulting team of 16 multi-discipline angioplasty

engineers and technicians.

. Maintained the program scope, milestones, budget reports, schedule and

business requirements.

. Executed material characterization, qualification and Technical Design

Input requirements for the product.

. Assessed existing technology capabilities and led DOE for clean room

process control improvements

. Collaborated with India team on corporate presentations and CAD and

database resource deliverables.

. Led initiatives for pilot process controls development, work

instructions, FMEA, test method validation.

. Conducted transfer of processes and equipment to vendors, site audits and

supply chain strategy.

. Led technology transfer efforts of catheter manufacturing capital

equipment to other international facilities.

. Leadership role for documentation requirements of V&V and quality

manufacturing and packaging efforts.

. Coordination of feasibility studies and product builds for catheter

design verification and validation.

Program Manager:

AMEC Engineering 2008

Direct hire at consulting firm to lead the multi-discipline project team

efforts at Dow Chemical facilities. The effort focused on facility

expansions for raw resin material storage, process flow, blending,

manufacturing and finished goods storage. Manufactured salt-water filter

membranes for large municipal desalinization plants.

. Managed firm architects and all professional engineering disciplines for

facility expansions and process design challenges in industrial regulated

environments. Including internal challenges for needed resources.

. Developed the contractual scope, deliverables, negotiated timeline

and presented financial reports.

. Led development of the work breakdown structure, critical path and

the project milestones.

. Field supervision, facility and equipment inspection, RFI

communication, construction trade coordination.

. Managed contractual project metrics and project plans based on earned

value methodology (EVM).

FDA Compliance and Validation Project Manager:

Boston Scientific 2005 - 2007

Managed all phases of the program. Led equipment evaluation, planning,

system design, validation and FDA compliance (21CFR Part 11) of equipment,

manufacturing processes, software, hardware, and electronic records. The

program interacted with manufacturing, testing, IT and packaging of medical

devices.

. Identified, developed and maintained the $1.2 million capital project

budget within five percent.

. Delivered authenticity of electronic data for FDA Part 11 compliance for

quality manufacturing decisions.

. Identified project stakeholders, created project activity list and

authored final reports.

. Validated and commissioned a 20% production capacity increase at two

production facilities (US and Mexico) utilizing value stream mapping of

critical material and quality information flow.

. Led CAPA related resolution identification and implementation processes

for medical device material flow, product assembly, packaging, labeling

equipment, custom software and SAP based projects.

. Led the sourcing and utilization of IT, DBA, software programmers, and

validation resources.

. Developed contractual specifications, oversaw authoring of software

requirements, test protocol development and the software requirements

trace matrix for electronically controlled systems.

. Interacted at the corporate with level external consultants, contractors,

contract manufacturers, inspectors, equipment suppliers, civic planners

and special interest activists.

. Influenced the technical team and held a cross-functional leadership role

with all business units including corporate and local IT, developers,

quality, regulatory, R&D, legal, procurement, accounting and security.

. Successfully implemented equipment site technology transfers validation,

commissioning and compliance of medical device facilities located in the

US, Ireland and Mexico.

Professional Consulting Engineer:

Beyond Engineering, Inc. 1995 - 2004

Provided professional corporate leadership, project management,

intellectual property strategy, engineering, compliance, quality reviews,

validation, liaison sales, commissioning and customized training services.

. Corporate engineering / sales liaison for NASA Glenn and JPL,

AeroVironment, Navy, Honeywell, Ball Aerospace, Mercury Marine, UOP,

Carrier, GE - Transportation, GM - Hummer, Gotec, Nuvera, and 3M.

. Industry exposure to food processing, bio/pharma, medical device,

retail and bulk packaged consumables.

. Regulatory environments included DoD, EPA, FDA, 3-A, NSF, UL, CE,

OSHA, ISO, and DOT.

. Mastered challenges in initial project / product requirements,

mechanical, electrical, electronic, pneumatic, hydraulic and chemical

engineering, motion control system design, material selection,

programming, validation, commissioning, contract fulfillment, CAD

standardization, BOM and schematic generation.

Owner of Industrial pump systems: Conducted the US market research, design

feasibility, ergonomics and developed a refrigerant pump system

requirements. Led the controls integration into other HVACR industrial

systems applications. Authored sales literature and proposals, interacted

with corporate clients and regulatory agencies, prepared project

milestones, budgets and developed the product testing protocol.

Designed and launched an EPA and UL approved (Section 608 and 609 of the

Clean Air Act) refrigerant pump and liquid refrigerant transfer system.

Owned the product design, quality, and government compliance.

. Created functioning prototypes

. Created industrial testing protocol

. Developed system standards / specifications

. Designed system schematics

. Implemented design quality improvements

. Reviewed design tolerances

. Collected performance data for EPA

. Interacted with UL and EPA leaders

. Generated assembly methods and BOM

. Authored user and safety manuals

. Designed product UL labels

. Led packaging design with vendor

. Authored 9-minute training video script

. Sole owner of the entire product

Reduced the cost of second version of the pump by 22 percent, maintaining

UL and EPA design compliance.

Customized these new refrigerant pump systems with control algorithms for

integration into other industrial and explosion-proof applications. Pump

systems were integrated with other COTS parts in these industries:

. Fuel cell implementation (trade secret: hydration of PEM fuel cell

membrane and liquid methanol injection)

. Biofuel and propane fuel injection pump and recirculation system

design and integration.

. Fuel additive dosing and blending systems meeting weights and measures

requirements.

. DNAPL hazardous groundwater Superfund waste cleanup techniques and

turnkey systems.

. LNAPL fuel spills, direct explosion-proof down-well fuel and water

remediation at Superfund sites.

. GM automotive turbo-charger pre-evacuation vacuum pump system

integration.

. GE locomotive service contract solution for on-board continuous oil

change pump system.

Other successful engineering consulting efforts during this period include:

. Led 42 human resources at the on-site technology transfer and

decommissioning of a medical device campus. The 400,000 s.f. manufacturing

facility with 26,000 assets, was dispositioned in six-months.

. Managed all consulting employees in engineering, CAD, technical and

office support roles.

. Delivered food-grade fluid handling solutions for Hunt-Wesson. Led the

design, fabrication and commissioning of a 3-A liquid net weight filling

system. This Coriolis metering of elevated temperature caramel and

chocolate was integrated into a new palletized net-weight filling system

for 55-gallon drums.

. Designed, fabricated and commissioned a manufacturing process improvement

at the 3M Chemolite facility. Process flow consistency for bulk reflective

micro-beads was delivered utilizing this custom system.

. Designed a Lean solution for an improved infant formula plastic bottle

sterilization system at Novartis.

. Led process development for software controlled dosing of lubricant for

fiber optic horizontal drilling rigs.

. Led design team implementing a turnkey in-line retail fuel distribution

additive blending process system that met accuracy for DOT weights and

measures requirements.

. Conducted on-the-floor LEAN studies of timed sequences and analyzed

process flow.

. Developed a 316L aseptic fermentation system for the Lifecore sodium

hyaluronate-based product.

Capital Equipment Design Engineer:

SciMed (Boston Scientific) 1989 - 1994 Accountable for strategic and

tactical planning for the execution of manufacturing process development

and equipment design for proprietary medical device prototyping,

manufacturing, testing and packaging. Led a team of engineers, CAD

designers, programmers, technicians and machinists.

. Developed processes and equipment for the manufacturing and testing of

angioplasty catheters, guide catheters, braiding, guide wires and early

coronary stent development.

. Implemented process and clean room equipment improvements based on worker

compensation claims.

. Led mechanical, electrical, pneumatic, PLC and software control system

design and documentation.

. Leadership, management, training and mentoring of team members and

contractors.

. Initiated and maintained project milestones by implementing Theory of

Constraints philosophy.

. Designed the first automated angioplasty catheter balloon molding

manufacturing system.

Systems Engineer: Massman Automation Designs,

Inc. 1988 - 1989

Developed custom process flow and capital equipment to efficiently test,

weigh, move or package fluorescent light bulbs, flood lamps, bulk beans,

frozen fish, liquid containers and retail packaged food products.

. Developed schematics and documented existing systems for custom automated

continuous motion and indexing filling systems as well as case-packing

equipment for domestic and international clients.

. Developed assembly drawings, mechanical and electrical diagrams, BOM, and

generated large pneumatic and electrical schematics. Programmed PLCs and

motion control devices.

. Existing client production line studies were conducted to determine

capacity and quality improvements.

. Listened, quoted, prototyped, developed, programmed, tested and installed

new automated solutions.

. Identified, designed and integrated new technology sensor feedback into

high-speed processing systems.

Education: B.S. Mechanical Engineering North Dakota State University

1988

Professional License: State of Minnesota 1994-present #MN23407

Project Management Institute Member: 2009-present #1148136

Personal Engineering Hands-on Skills:

. Computer savvy with Windows applications and network communications

. Programming of PLC ladder logic for GE and Allen Bradley

. Programming of stepper and servo motion control systems

. Schematic design integrating electro-mechanical computer controlled

systems

. Schematic creation for electrical, electronics and fluid systems (air

and oil)

. Machining, casting and surface finishing of aluminum, steel, stainless

steel and plastics

. Refrigeration sealed system design, charging and service

. Pneumatic and hydraulic logic, plumbing and troubleshooting

. Diagnostic tools such as multimeters, micrometers and pressure test

gauges

. Electrical wiring of Vac and Vdc panels, low voltage electronics

sensors and thermal feedback loops.

Engineering Presentation Skills:

Developed a comprehensive engineering curriculum and presented the

technical training. Provided training in person and via live interactive

video courses. These training courses include:

. Refrigeration Sealed System Design and Service

. OSHA workplace safety procedures

. Servo, VFD motor control theory

. Servomechanism motion control

. Measurements within manufacturing

. Inspection and calibration techniques

. PLC programming and troubleshooting

. Industrial sensors and process control

. Pneumatic and hydraulic system design

These courses were developed for and presented to technicians, engineers,

programmers and electricians, in both union and non-union environments. The

class sizes range from one-on-one coaching to over twenty students.

Technology presentations have been to audiences of 200.

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